Head of Drug Safety & Pharmacovigilance
About the Company
Clinical-stage biopharmaceutical company focused on building the future of oncological therapy.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking a Head of Drug Safety and Pharmacovigilance to provide strategic leadership and oversight of all safety and pharmacovigilance activities. The successful candidate will be responsible for ensuring compliance with US and global pharmacovigilance regulations, leading the medical review of safety cases, and maintaining a robust signal detection process. This role requires a strong background in safety governance, proactive benefit-risk assessments, and representation of PV in communications with health and regulatory authorities. The Head of Safety will also be involved in the design and implementation of risk management plans, as well as serving as a subject matter expert for drug safety-related regulatory reports and clinical study documents. Applicants must have a clinical degree (RN, PharmD, MD/DO) with at least 15 years of industry experience, including a significant background in PV for both clinical development and post-marketed products. Extensive experience with US health authorities in safety and pharmacovigilance, as well as a proven track record in leading and managing high-performing teams, is essential. The role demands excellent scientific, clinical, and analytical skills, in-depth knowledge of safety science and operations, and the ability to effectively interact with cross-functional partners. The Head of Safety will be expected to work in alignment with the company's core values and policies, and to demonstrate a strong commitment to science and patient care.
Hiring Manager Title
Chief Medical Officer
Functions
Head of Drug Safety & Pharmacovigilance • Boston, MA, United States
Vice President, Global Head of Regulatory Affairs.Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserve... Mostrar más
Leads the global Oral Drug Product organization and delivery of oral drug product development from early phase through commercialization and lifecycle management.Sets strategy and builds capabiliti... Mostrar más
Director, Study Quality And Compliance.This role oversees the Study Quality and Compliance team within the Toxicology line function of Preclinical Safety (PCS).This team is responsible for handling... Mostrar más
The Director of R&D Quality-Pharmacovigilance & Medical Affair is responsible for contributing to the development, implementation and maintenance of Quality Assurance systems and activities for Rep... Mostrar más
Director - Healthcare and Life Sciences - Pharma & Biotech.Simon-Kucher's sole focus is on unlocking better growth for our clients, increasing their long-term sales, value, and profit.We achieve th... Mostrar más
Vice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV).We seek an innovative colleague who will challenge conventional thinking about how biotech companies advocate for patients a... Mostrar más
Medical Director, Drug Safety & Pharmacovigilance.Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with sp... Mostrar más
Head Of Medical Information (Director/Senior Director) Medical Affairs.Join us in tackling autoimmune disease at its root.At Vor, we believe science can do more than manage symptoms.It can change ... Mostrar más
Director, DMPK - Pharmacokinetics & Clinical Pharmacology.Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than... Mostrar más
Our shared values and a deep commitment to improving patients' lives are the guiding principles that drive our work and connect our diverse and experienced teams to Kymera's mission.We strive to cr... Mostrar más
Director, Infection Prevention & Control.The Director, Infection Prevention & Control will oversee the Infection Control Program within the Department of Quality and Patient Safety at Dana-Farber C... Mostrar más
Join the engine of Sanofi's mission where deep immunoscience meets bold, AI-powered research.In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.As Head Of... Mostrar más
A trusted leader in medication dispensing serving healthcare and pharmaceutical regulations.The Company is seeking a Head of Cybersecurity to lead its small but growing cybersecurity team.The succe... Mostrar más
Principal, Medicinal ChemistryLinkedInTwitterEmailMessageShareResearch & DevelopmentCambridge, MA ID:26R-08 Full-Time/RegularThis position is currently based in our Cambridge, MA office.Please ... Mostrar más
Pharmacy Intern Career Opportunity.Encompass Health: Where Pharmacy Meets Heart, Home, and Healing.Looking for a pharmacy career rooted in purpose, close to your heart and home? At Encompass Health... Mostrar más
Provides empathetic pharmacy consulting services to patients regarding the effective use of medications and drug interaction awareness.Offers preventive and clinical healthcare services, including ... Mostrar más
Director, Health Economics & Outcomes Research (HEOR).AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical c... Mostrar más
Director, Regulatory and Safety Sciences Technology.Alnylam is the world's leading RNA interference (RNAi) company, dedicated to transforming the lives of patients through innovative medicines.As A... Mostrar más
Director Of Global Patient Safety.At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.We are seeking a Director to join our Patient Safet... Mostrar más
The Director, Medical Policy has responsibility for leading the organization's enterprise Medical Policy department activities.The Director leads, directs and modifies business processes and operat... Mostrar más
