NewExecutive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product Takeda PharmaceuticalExecutive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination ProductBoston, MAAs Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance. Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances.
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
NewSenior Director, Global Parenteral Drug Product Technical Services (MSAT) LillySenior Director, Global Parenteral Drug Product Technical Services (MSAT)Indianapolis, IN$163,500–$239,800Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). You will be accountable for ensuring that qualified resources, robust systems, and effective governance are in place to provide technical stewardship of commercial parenteral drug product processes across our entire manufacturing network – spanning both internal sites and external contract manufacturing partners.
Senior Director, Clinical Safety MD Daiichi Sankyo, Inc.Senior Director, Clinical Safety MDBasking Ridge, NJ$280,350–$467,250 / yearFull timeThe individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
NewVaccines Safety Sciences Lead CSLVaccines Safety Sciences LeadKing of Prussia, PAQualifications: • Bachelor degree, Medical Documentation, or equivalent in a life science discipline or Masters (or international equivalent) in science, medicine/health sciences, or epidemiology; or Bachelor degree (or international equivalent) in science, medicine/health sciences, or epidemiology with an increased experience requirement of an additional 3 years industry experience in a related role. • Leads or contributes important initiatives to write new processes, or improve/optimize current processes in the functional area; acts as an expert on cross-functional teams for process optimization where the input of safety sciences is required.
Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist) Xenon PharmaceuticalsDirector/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist)Needham, MassachusettsThe successful candidate will author safety documents, reviews safety sections of other documents, for Xenon products throughout the product lifecycle from First-in-Human (FIH) to post-marketing, performs QC, and, when necessary, assists in responding to information requests from Health Authorities for Xenon products, participate in cross-functional Safety Risk Management Team (SRMT) meetings and collaborate with colleagues in Clinical Development, Trial Operations, Clinical Pharmacology, Biostatistics & Programming, Regulatory, Medical Affairs, non-clinical safety lead, QA and Legal departments. * Support and review safety-related documents for Xenon products throughout product lifecycle from FIH to post-marketing such as Safety Assessment Reports, product labeling, risk management/risk mitigation-related documents, and responses to ad-hoc information requests by Health Authorities and internal stakeholders.
Associate Director/Director, Quality & Compliance (Drug Safety & Pharmacovigilance) Arrowhead PharmaceuticalsAssociate Director/Director, Quality & Compliance (Drug Safety & Pharmacovigilance)San Diego, CA$180,000–$230,000 / yearThe Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Drug Safety & Pharmacovigilance department. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
NewMedical Director, Drug Safety and Pharmacovigilance IDEAYA BiosciencesMedical Director, Drug Safety and PharmacovigilanceThe final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process. Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).
Manager, Global Drug Safety & Pharmacovigilance Bionique Testing Laboratories LLCManager, Global Drug Safety & PharmacovigilanceCary, North Carolina$120,000–$130,000Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence.
Manager, Global Drug Safety & Pharmacovigilance Veloxis Pharmaceuticals, IncManager, Global Drug Safety & PharmacovigilanceCary, North Carolina$120,000–$130,000Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence.
Manager, Global Drug Safety & Pharmacovigilance Asahi Kasei Battery Separator Canada CorporationManager, Global Drug Safety & PharmacovigilanceCary, North Carolina$120,000–$130,000Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence.
Associate Director, Global Drug Safety & Pharmacovigilance Scientist Genmab ASAssociate Director, Global Drug Safety & Pharmacovigilance ScientistPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Contribute to safety-related documents for Genmab products throughout product lifecycle from FIH to post-marketing, including robust safety surveillance, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g.
Manager, Global Drug Safety & Pharmacovigilance Asahi Kasei Semiconductor, Inc.Manager, Global Drug Safety & PharmacovigilanceCary, North Carolina$120,000–$130,000Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence.
Director, Global Drug Safety & Pharmacovigilance Physician Genmab ASDirector, Global Drug Safety & Pharmacovigilance PhysicianPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. You will work together with other Drug Safety staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders supporting the Team Lead.
Senior Director, Drug Safety and Pharmacovigilance BridgeBio Pharma IncSenior Director, Drug Safety and PharmacovigilanceNY$222,300–$255,000 / yearConfigure and administer the Veeva Safety platform (Vault Safety Suite: Safety, SafetyDocs, Signal, Workbench), including user administration, workflow routing, coding configurations (MedDRA, WHO Drug), and business rules. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.
Senior Director, Drug Safety And Pharmacovigilance Annexon, Inc.Senior Director, Drug Safety And PharmacovigilanceSan Francisco, CARemote$300,000–$375,000 / yearAuthors, reviews and provides input as applicable for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator's Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI). Lead the analysis, identification and reporting or possible trends and concerns regarding compounds and key related products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
Director, Drug Safety & Pharmacovigilance Xencor, Inc.Director, Drug Safety & PharmacovigilanceSan Diego, CARemote$206,000–$255,000 / yearThorough understanding of the drug development process in relation to safety surveillance activities in clinical trialsAbility to establish effective working relationships with people in a wide variety of disciplines and backgroundsAbility to manage and prioritize multiple projects and demands simultaneously, rapidly adjust to changing priorities, and work effectively under pressureKnowledge and understanding of all relevant global PV regulations, FDA, EU and ICH guidelines, initiatives and regulations governing clinical trial safety environmentsFamiliarity with Argus safety databaseKnowledge and training on MedDRA dictionary with relevance to adverse event codingExcellent interpersonal skills and professionalismExcellent time management and organizational skillsStrong analytical, assessment and problem-solving skillsAbility to read, analyze and interpret complex clinical data and informationAbility to demonstrate competencies applicable for job based on Xencor's Leadership Competency ModelAbility to effectively manage others through coaching and supervision, in accordance with company policies and practices. Reviews and provides safety functional input for development of protocols, IBs, ICFs, CSRs and other relevant study documentsActs as lead author for aggregate safety reports (e.g., DSURs)Leads efforts related to ad hoc and routine signal evaluationProvides Drug Safety/PV subject matter expertise on cross-functional platforms and teams throughout the companyProvides end to end Drug Safety/PV support for assigned products including study start up activities, vendor plans, signal detection plans, SAE review, aggregate data review, signaling, aggregate authoring including DSURs, annual core product document updates (IB, ICF), and CSR authoring as well as informed consent forms, integrated summaries of safety, marketing applications and other regulatory submission documents on assigned products.
Senior Manager, Drug Safety And Medical Monitor SupernusSenior Manager, Drug Safety And Medical MonitorRockville, MD$131,000–$155,000 / yearConduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead. Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator's Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.
Senior Manager, Drug Safety and Medical Monitor Supernus Pharmaceuticals IncSenior Manager, Drug Safety and Medical MonitorRockville, MD$131,000–$155,000 / yearConduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead. Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator's Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.
Vice President, Drug Safety and Pharmacovigilance DSPV Immunovant IncVice President, Drug Safety and Pharmacovigilance DSPVNew York, NY$400,000–$425,000 / yearMedical expert accountable for overall DSPV strategy and all deliverables of the DSPV function, including responsibilities for pharmacovigilance-related documents (e.g., DSUR) as well as safety sections of key documents (e.g., IBs, RSI, ICFs, study protocols, CSRs) and other applicable activities (IND/CTA, requests for information, regulatory responses). Responsible for oversight of the DSPV department, including building and managing a team of DSPV professionals (operations and safety science) to execute the development strategy and support registrational/post-marketing activities in a compliant and collaborative environment, in accordance with long-term strategic goals.
Drug Safety Analyst BelcanDrug Safety AnalystLos Angeles, CA$42–$45.70 / hourAbility to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines-Proficient in Windows 7 and MS Office (Excel, PowerPoint, Visio, Word)- Familiarity with validation of computer systems and/or GMP environments is essential.- Work as Signal Analyst during signal management activities including extractions of signal detection reports ensuring document filing and archivingEnsure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities:1.
Drug Safety Physician SystimmuneDrug Safety PhysicianPrinceton, NJFull timeThis individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
Associate Director/Director, Drug Safety & Pharmacovigilance Quality & Compliance Arrowhead Pharmaceuticals IncAssociate Director/Director, Drug Safety & Pharmacovigilance Quality & ComplianceSan Diego, CA$180,000–$230,000 / yearThe Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Drug Safety & Pharmacovigilance department. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology)Boston, MAThis role is responsible for establishing and executing global safety strategy across early- and mid-stage clinical programs, with particular focus on immune-mediated toxicities, oncology risk management, and complex benefit-risk assessment. The Director of Drug Safety & Pharmacovigilance provides strategic and hands-on leadership for pharmacovigilance activities supporting a clinical-stage biotech pipeline in inflammatory and oncology diseases.
Director, Drug Safety and Pharmacovigilance Annexon IncDirector, Drug Safety and PharmacovigilanceSan Francisco, CA$292,000–$315,000 / yearAuthors, reviews and provides input as applicable for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator's Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI). Lead the analysis, identification and reporting or possible trends and concerns regarding compounds and key related products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
Vice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV) Hemab ApSVice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV)Boston, MADevelop processes for and provide safety medical oversight of safety surveillance and benefit risk assessments, including medical review of ICSRs, signal management activities, safety analyses, benefit risk profile development and monitoring, and risk mitigation strategies. This role requires a hands-on leader with robust medical and operational expertise, a strong understanding of global regulatory requirements, and the ability to design and oversee a robust fit-for-purpose safety system that scales with company growth to support excellence in Drug Safety & Pharmacovigilance as a critical part of our mission.
Director, Drug Safety & Pharmacovigilance Xencor IncDirector, Drug Safety & PharmacovigilanceSan Diego, CARemote$206,000–$255,000 / yearProvides end to end Drug Safety/PV support for assigned products including study start up activities, vendor plans, signal detection plans, SAE review, aggregate data review, signaling, aggregate authoring including DSURs, annual core product document updates (IB, ICF), and CSR authoring as well as informed consent forms, integrated summaries of safety, marketing applications and other regulatory submission documents on assigned products. Our focus is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions.
Director, Drug Safety & Pharmacovigilance - Safety Scientist Travere Therapeutics IncDirector, Drug Safety & Pharmacovigilance - Safety ScientistSan Diego, CARemote$189,000–$246,000 / yearWe stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Associate Director/Director, Quality & Compliance Drug Safety & Pharmacovigilance Arrowhead Pharmaceuticals IncAssociate Director/Director, Quality & Compliance Drug Safety & PharmacovigilanceSan Diego, CAThe Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Drug Safety & Pharmacovigilance department. Proactively provide Good Pharmacovigilance Practice (GVP) support for clinical, post marketing and commercial activities including PV/ safety systems to protect patient safety and well-being, maintain data integrity, and support implementation of Quality Systems.
Pharmacovigilance & Drug Safety Specialist (PharmD) Pharmacy CareersPharmacovigilance & Drug Safety Specialist (PharmD)North CarolinaAnalyze adverse event reports and clinical trial safety data. Collaborate with medical affairs and clinical teams to address safety signals.
Manager, Global Drug Safety & Pharmacovigilance Asahi Kasei Plastics North America, Inc.Manager, Global Drug Safety & PharmacovigilanceCary, North Carolina$120,000–$130,000Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence.
Drug Safety Specialist III Karwell TechnologiesDrug Safety Specialist IIIRemote, NJRemoteIdentify adverse events, seriousness, and listedness / labeledness for case assessment; review additional incoming information to determine reportability. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Purdue organization.
Drug Safety Scientist Grifols SADrug Safety ScientistClayton, NCAssist the Drug Safety Coordinators with data entry of adverse event cases, submissions, importing of e2b casess, and case statuse log management and booking in cases into the database when volumne is high or other situations as determined by the Director of Operations. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
NewMedical Officer Pharmacovigilance Drug Safety Saratoga Medical CenterMedical Officer Pharmacovigilance Drug SafetyRockville, MDSaratoga Medical (DBA Saratoga Ascend) has an exciting opportunity for a Senior Medical Officer - Pharmacovigilance & Drug Safety to support DMID-sponsored clinical trials in Rockville, MD. This is a great opportunity for experienced physicians seeking to provide medical safety oversight and pharmacovigilance support in a collaborative clinical research environment.
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics, IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology)Boston, MassachusettsFull timeThis role is responsible for establishing and executing global safety strategy across early‑ and mid‑stage clinical programs, with particular focus on immune‑mediated toxicities, oncology risk management, and complex benefit–risk assessment. Overview: The Director of Drug Safety & Pharmacovigilance provides strategic and hands‑on leadership for pharmacovigilance activities supporting a clinical‑stage biotech pipeline in inflammatory and oncology diseases .
Manager, Global Drug Safety & Pharmacovigilance Asahi Kasei Advance AmericaManager, Global Drug Safety & PharmacovigilanceCary, North Carolina$120,000–$130,000Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence.
Manager, Global Drug Safety & Pharmacovigilance Bionique ScientificManager, Global Drug Safety & PharmacovigilanceCary, North Carolina$120,000–$130,000Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence.
Drug Safety Scientist Integrated Resources, IncDrug Safety ScientistRockland, MassachusettsFull timeParticipate in the set-up and approval of local clinical trials by developing drug safety manuals and SAE reconciliation plans, and conducting CRF reviews, and collaborating with US Drug Safety Medicine and GDS for the development and execution of Clinical Development plan as needed. Drug Safety ScientistTo utilize medical knowledge and operational expertise to ensure patient safety by performing medical assessment of adverse events, assembling up-front safety information, collecting quality follow-up and ensuring medical information is included in cases for investigational and marketed products.
Senior Director of Drug Safety XtalPi IncSenior Director of Drug SafetySan Diego, CAWorking at the interface of computational design, translational biology and preclinical development, you will integrate mechanistic toxicology, pharmacology, DMPK and emerging clinical insights to enable informed, data-driven programme decisions and successful human translation. Reporting to the VP, Head of In Vivo Bioscience, the role will shape nonclinical and translational safety strategies supporting the progression of novel biologics, multi-specific antibodies and peptide therapeutics from discovery through early clinical development.
Executive Director, Drug Safety (MD) Nektar TherapeuticsExecutive Director, Drug Safety (MD)MD$360,000–$400,000 / yearNektar currently anticipates the base salary for the Executive Director, Drug Safety (MD) to range from $360,000 to $400,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience. This role requires a senior medical leader who can operate at the intersection of science, regulation, and business strategy-translating complex safety data into actionable guidance for executive leadership and regulatory bodies.
Drug Safety Associate I (Contractor) Corbus Pharmaceuticals Holdings IncDrug Safety Associate I (Contractor)The Drug Safety Associate I will support ICSR case processor, managing end-to-end intake and data entry in Veeva Vault Safety and ensuring expedited regulatory submissions meet ICH E2B and FDA/EMA timelines. Corbus' lead oncology program, CRB-701, is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4-expressing tumors and is being developed for multiple solid tumor indications.
Drug Safety Associate I Corbus Pharmaceuticals Holdings IncDrug Safety Associate IThe Drug Safety Associate I will serve as the primary ICSR case processor, managing end-to-end intake and data entry in Veeva Vault Safety and ensuring expedited regulatory submissions meet ICH E2B and FDA/EMA timelines. Corbus' lead oncology program, CRB-701, is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4-expressing tumors and is being developed for multiple solid tumor indications.
Drug Safety Physician Systimmune IncDrug Safety PhysicianPrinceton, NJ$150,000–$250,000 / yearThis individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
Drug Safety Associate I Integrated Resources, IncDrug Safety Associate IHorsham, PennsylvaniaContractorPRINCIPAL RESPONSIBILITIES: Case processing: 95% Definition: The completion of full case information on the database, including quality review to ensure accuracy and completeness Activities Include: May Triage and classify ICSRs for report type, seriousness, causality, expectedness/labeling and reporting; prioritize ICSR according to regulatory requirements Confirmation of Safety Coordinator case registry data Database searches as necessary Completion of remaining case data entry, including narrative or auto-narrative Completion of risk and quality (label, approval, manual coding and quality review steps). Pharmaceutical industry experience is preferredRequired Skills/Abilities Intermediate Information Technology Skills Data entry experience desired Accountability for delivery of results Decision making skills Problem solving skills Proactive approach/uses own initiative Manages owe work, able to prioritize, plan and organize work assignments and work under strict timelines Ability to follow guidelines, working practices etc.
Signal Detection/Drug Safety Associate II Integrated Resources, IncSignal Detection/Drug Safety Associate IIBridgewater, New JerseyContractorJob DescriptionJob Title: Signal Detection/Drug Safety Associate IIJob Location: Bridgewater, NJClient –Sanofi (5822901)Duties:Please note: The Job Title is Signal Detection and Management Associate Primary Responsibilities: The contractor resource will be the key contact on the SM Simplification Project work streams Bring industry expertise to support the Simplification Project and will provide strategic feedback to GSS and project team. Coordinate and lead SMC meetings Experienced in signal detection tools and processes Skilled in implementing new business processes and technology solutions for signal detection in clinical development Experienced in LEAN methodology Working knowledge of regulations related to signal detection (GVP Module IX).
Drug Safety Specialist III Katalyst Healthcares & Life SciencesDrug Safety Specialist IIIRemote, NJRemoteIdentify adverse events, seriousness, and listedness / labeledness for case assessment; review additional incoming information to determine reportability. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Purdue organization.
NewSenior Specialist, Drug Safety CRISPR Therapeutics AGSenior Specialist, Drug SafetySouth Boston, MA$105,000–$115,000 / yearThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction.
Drug Safety Public Health Coordinator Integrated Resources, IncDrug Safety Public Health CoordinatorFoster City, CaliforniaContractorMay perform initial data entry of ICSRs (review, extract, accurately enter AE data from ICSR reports).May interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries. Participate in department projects, as required and will be cross-trained to handle other functions as deemed necessaryRecognizes situations that require assistance from more senior staff members and seeks assistance from appropriate internal and external resources.
Drug Safety Coordinator Integrated Resources, IncDrug Safety CoordinatorFlorham Park, New JerseyFull timeDuties & Responsibilities-Entry of AE information into the safety database, executing database queries and reportsPerforming active follow-up via verbal or written contact with healthcare professionals (MDs, RNs, etc.) and consumersCoding verbatim AE terms, medical history, laboratory data, and drugs using MedDRA and WHO-Drug dictionariesReconciliation of safety information received from external organizations, exchanged with corporate partners, and obtained from clinical trialsTrain other department staff regarding handling of safety information as neededAssist in compiling regulatory reports (e.g., PADER).Perform other duties as required. Will be responsible for several portions of the adverse event case processing workflow including but not limited to receipt, evaluation, registration, partial data entry, documentation, and reporting of adverse event information from Clinical trial and post-marketing adverse event cases in accordance with company SOPs and US and worldwide regulations.
Drug Safety Health Specialist Integrated Resources, IncDrug Safety Health SpecialistFoster City, CaliforniaContractorWill liaise with clinical department, affiliate, marketing or contract research organizations as needed on safety data issues (i.e., obtaining clarification or follow-up information).Meet specific data and quality targets for case handlingRemain current with case handling SOPs, guidance documents and database technologyOrganizes workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR.Demonstrates general understanding of appropriate labeling documents for Client products. Supports MSC Coding Group if assigned and ensures coding of adverse event and medication terms for clinical and post-marketing data using the MedDRA and WHO Drug coding dictionaries, and collaborates with Clinical Data Management (CDM) to ensure timely completion of coding jobs.