St. Luke's Health Network, Inc.Pharmacist, Investigational Drug Services St. Luke's Health Network, Inc.Pharmacist, Investigational Drug ServicesBethlehem, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Planning and execution of study-specific blinding and unblinding plans for investigational products, ensuring compliance with protocol requirements, maintaining trial integrity, and coordinating with pharmacy and clinical teams to support blinded study operations.
Carle HealthNewMedication Safety and Quality Pharmacist - Inpt Rx-D Carle HealthMedication Safety and Quality Pharmacist - Inpt Rx-DUrbana, ILAt Carle Health, we‘re committed to fostering a workplace where every team member feels valued, respected and empowered, where passion and purpose come together to positively impact the lives of our patients and our communities. The actual compensation offered a candidate will be dependent on a variety of factors including, but not limited to, the candidate’s experience, qualifications, location, training, licenses, shifts worked and compensation model.
Acadia Pharmaceuticals IncDirector Drug Safety & Pharmacovigilance Medical Safety Acadia Pharmaceuticals IncDirector Drug Safety & Pharmacovigilance Medical SafetyPrinceton, NJ$221,000–$275,700 / yearThe Director contributes product-level medical input to cross-functional safety governance, collaborates with the Executive Director of Medical Safety on complex or escalated safety issues, and supports regulatory submissions and health authority interactions for assigned products. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
Parexel International CorpSenior Physician, Patient Safety (Senior Drug Safety Physician) Parexel International CorpSenior Physician, Patient Safety (Senior Drug Safety Physician)NCProviding medical inputs into, and supporting the preparation of key regulatory documents including but not limited to, Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Signal Evaluation Reports (SERs), Health Authority (HA) response documents, Development Safety Update Reports (DSURs), Clinical Overviews (COs), Addendum to Clinical Overview (ACOs), Health Hazard Evaluation reports (HHEs), etc. Review and sign off Data Management line listings (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication, efficacy end points), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities.
Xenon PharmaceuticalsDirector/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.
ParexelSenior Physician, Patient Safety (Senior Drug Safety Physician) ParexelSenior Physician, Patient Safety (Senior Drug Safety Physician)Olympia, WAProviding medical inputs to case processing team + Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional) + Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative + Identify and resolve case issues, coordinate with client therapeutic/legal team + Provide guidance to junior physicians on case assessment methodologies **Periodic reports (as applicable)** + Reviewing and/ or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs + Providing medical inputs into, and supporting the preparation of key regulatory documents including but not limited to, Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Signal Evaluation Reports (SERs), Health Authority (HA) response documents, Development Safety Update Reports (DSURs), Clinical Overviews (COs), Addendum to Clinical Overview (ACOs), Health Hazard Evaluation reports (HHEs), etc. **Key Accountabilities:** **General** + Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting + Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee + Interacting with internal and external stakeholders for resolving issues + Attending and/ or presenting at client/cross functional meetings along with other stakeholders.
ParexelPatient Safety Associate I (Drug Safety Associate I) ParexelPatient Safety Associate I (Drug Safety Associate I)Olympia, WAAs a Patient Safety Associate I, you'll be responsible for several key activities including processing Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency, conducting comprehensive literature searches and reviews to identify safety signals, and supporting signal detection and management activities. We're looking for candidates with strong attention to detail and commitment to quality, an understanding of drug safety regulations and pharmacovigilance principles, excellent organizational and time management skills, the ability to work collaboratively in a team environment, and strong written and verbal communication skills.
Arrowhead PharmaceuticalsAssociate Director/Director, Drug Safety & Pharmacovigilance (Quality & Compliance) Arrowhead PharmaceuticalsAssociate Director/Director, Drug Safety & Pharmacovigilance (Quality & Compliance)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.
Arrowhead PharmaceuticalsAssociate 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.
Crinetics PharmaceuticalsVice President, Drug Safety/Pharmacovigilance Crinetics PharmaceuticalsVice President, Drug Safety/PharmacovigilanceThe incumbent will design and develop the Global Crinetics Drug Safety and Pharmacovigilance system, ensuring adequate resourcing, efficient and compliant safety reporting, designing implementation of Safety Surveillance Programs, oversight of the safety profiles of Crinetics products and playing a leading role in safety risk management activities. Together with Clinical Research, provide drug safety oversight of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs.
Crinetics Pharmaceuticals IncVice President, Drug Safety/Pharmacovigilance Crinetics Pharmaceuticals IncVice President, Drug Safety/PharmacovigilanceCA$339,000–$424,000 / yearThe incumbent will design and develop the Global Crinetics Drug Safety and Pharmacovigilance system, ensuring adequate resourcing, efficient and compliant safety reporting, designing implementation of Safety Surveillance Programs, oversight of the safety profiles of Crinetics products and playing a leading role in safety risk management activities. • Together with Clinical Research, provide drug safety oversight of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs.
Zenas BioPharma (USA) LLCMedical Director - Drug Safety & Pharmacovigilance Zenas BioPharma (USA) LLCMedical Director - Drug Safety & PharmacovigilanceWaltham, MA$246,400–$308,000 / yearZenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases.
Arrowhead Pharmaceuticals IncAssociate 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.
Annexon IncDirector, Drug Safety and Pharmacovigilance Annexon IncDirector, Drug Safety and PharmacovigilanceSan Francisco, CARemote$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.
Artech LLCDrug Safety Public Health Specialist - II* Artech LLCDrug Safety Public Health Specialist - II*Foster City, CA, CA$41–$46.57 / hourThe candidate will work cross-functionally, contribute to projects, support training initiatives, and may lead workstreams or process improvements. This role focuses on ensuring compliance with drug safety processes, including the collection, evaluation, processing, and submission of adverse event (AE) data.
Xencor IncDirector, 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.
Arrowhead Pharmaceuticals IncAssociate 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.
Neumora Therapeutics IncMedical Director/Senior Medical Director, Drug Safety and Pharmacovigilance Neumora Therapeutics IncMedical Director/Senior Medical Director, Drug Safety and PharmacovigilanceSan Diego, CA$280,373–$363,780 / yearThe Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance will manage the safety aspects of Neumora clinical studies, in collaboration with pharmacovigilance operations, clinical development, clinical operations, toxicology, and other clinical and pre-clinical functions, to provide medical insights and promote integration of drug safety strategies in Neumoras development programs. Contributes to the analysis and interpretation of data generated internally or externally and presents study updates, interim results, and final headline data to senior management as required.
Genmab ASAssociate 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.
Ionis Pharmaceuticals IncAssistant Director, Drug Safety Surveillance Ionis Pharmaceuticals IncAssistant Director, Drug Safety SurveillanceCarlsbad, CA$132,140–$170,189 / yearWith multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. Core responsibilities include leading or supporting high quality production of aggregate reports, RMPs/dRMPs, signal evaluation reports, signal detection management (eg, data evaluation, presentation, meeting coordination, etc.), and literature surveillance.
Supernus Pharmaceuticals IncSenior Manager, Drug Safety Supernus Pharmaceuticals IncSenior Manager, Drug SafetyRockville, MD$130,000–$155,000 / yearJob Summary: The Senior Manager of Drug Safety will support drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies including initial safety review of adverse events and medical review of clinical data, interaction with drug safety vendors, review of source documents, and preparation of documents for submission to regulatory authorities. Support the clinical research team in the preparation/review of safety reports/data; e.g., Annual Reports, cumulative SAE reports, safety database reports, clinical study reports, MedWatch Reports, Tables/Listings/Figures, and other reports as deemed necessary.
BelcanDrug 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.
SystimmuneDrug 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).
Braveheart BioVice President, Drug Safety & Pharmacovigilance Braveheart BioVice President, Drug Safety & PharmacovigilanceSan Francisco, CaliforniaLead aggregate safety reporting (DSURs, IND annual reports, periodic line listings) and IB updates, Lead safety strategy and benefit-risk assessment across protocols, IBs, CSRs, and integrated summaries (ISS), ensuring consistency with the overall clinical development and regulatory strategy. The VP will partner with an established Senior Director of PV (a direct report) to design the PV operating model, select CRO/PV vendor partners, establish the safety governance framework, and represent Safety in cross-functional and regulatory interactions.
Net2SourceDrug Safety Public Health Specialist - II Net2SourceDrug Safety Public Health Specialist - IIFoster City, CA$42–$46.90 / hourPerforms routine and non-routine daily case management activities independently and provides direction as needed to junior staff assists junior staff as needed. • Actively participates in internal and cross functional teams as a representative of functional group; may lead functional work streams as required.
ICONMA, LLCDrug Safety Public Health Specialist - II ICONMA, LLCDrug Safety Public Health Specialist - IIFoster City, CA$44.60–$46.90 / hourPerforms routine and non-routine daily case management activities independently and provides direction as needed to junior staff assists junior staff as needed. Actively participates in internal and cross functional teams as a representative of functional group; may lead functional work streams as required.
Nuvalent IncAssociate Medical Director, Drug Safety and Pharmacovigilance PV Nuvalent IncAssociate Medical Director, Drug Safety and Pharmacovigilance PV$210,000–$235,000 / yearContribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports. The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.
Arrowhead PharmaceuticalsAssociate Director, Drug Safety Operations Arrowhead PharmaceuticalsAssociate Director, Drug Safety OperationsSan Diego, CA$170,000–$200,000 / yearSupport Case Processing and support safety medical review, generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed and work with CRO to determine when cases are complete and ready to close. 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.
Immunovant IncVice 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.
Karwell TechnologiesDrug 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.
CRISPR Therapeutics AGSenior 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.
Monte Rosa Therapeutics IncDirector, 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.
Axelon Services CorporationDrug Safety Associate Axelon Services CorporationDrug Safety AssociateStamford, CTFull timeSummary: Shift hours: 8am to 4pm or 9am to 5pm Mon-Fri Responsibilities: Perform case processing activities including triage, data entry, and report distribution. Perform additional tasks as assigned, work independently, assess matters, propose resolutions, and appropriately escalate internally.
Biogen IncHead of PV & Drug Safety, West Coast Hub Biogen IncHead of PV & Drug Safety, West Coast HubSan Francisco, CA$281,000–$387,000 / yearRegular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
BraccoSenior Manager, Drug Safety Operations BraccoSenior Manager, Drug Safety OperationsPrinceton, FloridaEffective interaction and coordination with other Drug Safety staff, as well as personnel from other departments within Medical and Regulatory Affairs (Medical Affairs & Scientific Information, Clinical Research, Biometrics and Medical Writing, Medical Planning and Management, Regulatory) to assure regulatory compliance and support to drug safety related activities. The Senior Manager, Safety Operations – DSPUS is in responsible for overseeing pharmacovigilance operational and compliance activities for the Americas and ROW regions, ensuring full and continuous compliance with global and local regulatory requirements with a primary focus on Blue Earth Diagnostic Inc.
Systimmune IncDrug 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).
Katalyst Healthcares & Life SciencesDrug 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.
Arrowhead Pharmaceuticals IncAssociate Director, Drug Safety Operations Arrowhead Pharmaceuticals IncAssociate Director, Drug Safety OperationsSan Diego, CASupport Case Processing and support safety medical review, generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed and work with CRO to determine when cases are complete and ready to close. • Partner with safety systems and vendor teams to support oversight of the Safety Database (e.g., Argus), including UAT, system updates, data outputs for DSURs, IBs, DSMB/DSC materials, and business continuity activities.
CRISPR Therapeutics AGSenior Manager, Drug Safety CRISPR Therapeutics AGSenior Manager, Drug SafetySouth Boston, MA$140,000–$155,000 / 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.
CRISPR TherapeuticsSenior Specialist, Drug Safety CRISPR TherapeuticsSenior Specialist, Drug SafetySouth Boston, MassachusettsThe 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.
Exelixis IncDrug Safety Associate III Exelixis IncDrug Safety Associate IIIalameda, CA$124,500–$177,000 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or, MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience; or, PhD in Nursing, Pharmacy, other clinical, or related discipline and 0 or more years of related experience; or, Equivalent combination of education and experience. This role provides support for all major tasks and oversight of outsourced vendors, related to the management and best utilization of case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations and Global Patient Safety department procedures in all aspects of drug safety case processing and reporting.
Monte Rosa Therapeutics, IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics, IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology)Boston, MassachusettsThis 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.
Nurix Therapeutics IncDrug Safety Physician Nurix Therapeutics IncDrug Safety PhysicianBrisbane, CAYou will report to the VP of pharmacovigilance and work closely with colleagues in clinicaldevelopment, regulatory affairs, and clinical research to interpret emerging safety signals, support regulatory submissions, and maintain a strong safety framework during clinical development and transition into the post-marketing phase. This role is well suited for a physician who enjoys working at the intersection of non-clinical data, clinical medicine, data interpretation, and drug development, and who wants to have a meaningful impact on how new therapies are evaluated and brought to patients.
Medpace, Inc.Drug Safety Associate (Life Sciences Degrees) Medpace, Inc.Drug Safety Associate (Life Sciences Degrees)Cincinnati, OhioQualifications : Bachelor’s degree in life/health science including, but not limited to, Microbiology, Biology, Pharmaceutical Science, Chemistry, or related field; Proficient knowledge of Microsoft® Office; Broad knowledge of medical terminology; and. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
TalentBurst, Inc.US_Drug Safety Consultant II TalentBurst, Inc.US_Drug Safety Consultant IIChicago, ILRemoteThe PV Scientist may be responsible for overseeing day to day safety operations of clinical trials for the assigned product(s), supporting and/or leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings) and RMPs, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV activities. Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned to ensure alignment with safety strategy and risk communications.
Biogen IncSr Associate II, Drug Safety Biogen IncSr Associate II, Drug SafetyCambridge, MA$106,000–$138,000 / yearRegular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. Ensures all AE case processing, in both the Post-Marketing and Clinical Trial settings, is conducted in compliance with regulatory requirements, corporate and departmental procedure and data handling conventions by maintaining and executing oversight plans for vendors (CROs) with case processing responsibilities.
BiogenAssociate Medical Director, Global Drug Safety BiogenAssociate Medical Director, Global Drug SafetyCambridge, MassachusettsRegular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: Medical, Dental, Vision, & Life insurances.
IconmaDrug Safety Public Health Specialist - II IconmaDrug Safety Public Health Specialist - IIFoster City, CA$44.60–$46.90 / hourPerforms routine and non-routine daily case management activities independently and provides direction as needed to junior staff assists junior staff as needed. Actively participates in internal and cross functional teams as a representative of functional group; may lead functional work streams as required.
Pharmavise CorporationDrug Safety Pharmaceutical Consultants Pharmavise CorporationDrug Safety Pharmaceutical ConsultantsMaple Grove, MARemoteConduct signal detection activities to identify potential safety concerns associated with drug products and collaborate with cross-functional teams to mitigate risks. Support regulatory submissions and interactions with health authorities related to drug safety, including responses to safety-related inquiries and requests for information.
Worldwide Clinical Trials Holdings IncSenior Drug Safety Associate, Pharmcoviligence - US - Remote Worldwide Clinical Trials Holdings IncSenior Drug Safety Associate, Pharmcoviligence - US - RemoteResearch Triangle Park, NCRemoteWe are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting).