NewPharmcy Sys Speclst -Inj Drugs B. BRAUN MEDICAL (US) INCPharmcy Sys Speclst -Inj DrugsAtlanta, GA$80,000–$95,000 / yearTo gain access to our Healthcare Customers clinical settings, field sales, field service, and other customer facing professionals are required to register with the vendor credentialing organization associated with the Healthcare Customers, complete the Healthcare Customers’ required process, and undergo a series of clearances. Many of our Healthcare Customers require outside vendors like us to present proof that they have certain requisite vaccinations and immunizations, including, but not limited to, vaccinations against COVID-19 and seasonal influenza, before being granted entry into the Healthcare Customers’ clinical settings.
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.
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.
Medical 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).
NewManager, 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.
VP of Drug Safety/Pharmacovigilance Compass Therapeutics IncVP of Drug Safety/PharmacovigilanceBoston, MA$325,000–$450,000 / yearProvide executive oversight and review of safety-related regulatory submissions, cross functionally collaborating with Clinical, Medical, Quality, and Regulatory, including DSURs, DCSI, Risk Management Plans, Investigator Brochures, Clinical Study Report, Informed Consent Forms (ICFs), protocols, reports, other required safety documentation in accordance with legal requirements, respective SOPs and Health Authority. Ensure patient safety by monitoring patient safety profiles to identify and mitigate potential risks associated with Compass drugs; recommend updates to Development Core Safety Information (DCSI)/Reference Safety Information, communicate risks to applicable stakeholders.
NewManager, 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.
NewManager, 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.
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.
NewManager, 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.
Director, Drug Safety & Pharmacovigilance Scientist Dyne TherapeuticsDirector, Drug Safety & Pharmacovigilance ScientistWaltham, MA$220,000–$240,000 / yearThe Director collaborates across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners to support proactive safety oversight and informed program decision-making. Cross-Functional Leadership & Safety Governance Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external vendors to integrate safety considerations into study conduct and program strategy.
Medical Director, Drug Safety and Pharmacovigilance Ideaya Biosciences IncMedical Director, Drug Safety and PharmacovigilanceSouth San Francisco, CA$268,000–$331,000 / yearThe 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).
Sr. Medical Director, Drug Safety & Pharmacovigilance Scholar RockSr. Medical Director, Drug Safety & PharmacovigilanceCambridge, MABy harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for the compounds with support from cross-functional teams.
Director, 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.
NewManager, Global Drug Safety & Pharmacovigilance Crystal IS, 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.
NewManager, Global Drug Safety & Pharmacovigilance Asahi Kasei 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.
NewManager, Global Drug Safety & Pharmacovigilance Asahi Kasei Bioprocess America, 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.
Senior Manager, Drug Safety And Medical Monitoring SupernusSenior Manager, Drug Safety And Medical MonitoringRockville, 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.