Drug Safety Manager – US

Job Title: Director of Pharmacovigilance, Drug Safety

Location: USA – Remote

Department: Drug Safety / Pharmacovigilance

Reports To: VP, Clinical Development / Chief Medical Officer

About the Company

Our Biotech is a leading biotechnology company focused on the discovery, development, and commercialization of innovative therapies to address unmet medical needs. Our mission is to transform patient lives through groundbreaking science and a passion for innovation. We are a dynamic and growing team committed to integrity, collaboration, and excellence in everything we do.

Position Summary

The Director of Pharmacovigilance (PV) will lead and oversee all global pharmacovigilance activities for the company’s development and marketed products. This individual will be responsible for the strategic and operational implementation of the safety monitoring programs, ensuring compliance with regulatory requirements and internal policies. The ideal candidate has strong leadership skills, extensive knowledge of global PV regulations, and experience in both pre- and post-marketing environments.

Key Responsibilities

• Lead the development, implementation, and maintenance of the pharmacovigilance system across all phases of the product lifecycle.
• Oversee the collection, assessment, and reporting of adverse event (AE) data from clinical trials, post-marketing surveillance, and literature.
• Ensure timely submission of expedited and periodic safety reports (e.g., SUSARs, PSURs/PBRERs, DSURs) to regulatory authorities.
• Provide strategic safety input into clinical development plans, protocols, investigator brochures, and product labeling.
• Chair or support internal Safety Review Committees and represent PV at cross-functional meetings.
• Collaborate with Regulatory Affairs, Clinical Development, Medical Affairs, and Quality Assurance to ensure alignment on safety matters.
• Manage relationships with PV vendors and CROs, including contract negotiations and performance oversight.
• Lead the signal detection and risk management process, including development of Risk Management Plans (RMPs) and REMS programs as applicable.
• Maintain and ensure readiness for regulatory inspections and audits.
• Lead and develop a high-performing PV team, providing mentorship and growth opportunities.

Qualifications

• Advanced degree (MD, PharmD, PhD, or equivalent) in a life science or health-related field; MD preferred.
• Minimum of 10 years of pharmacovigilance experience in the biotechnology or pharmaceutical industry, with at least 3–5 years in a leadership role.
• In-depth knowledge of US (FDA) and global (EMA, ICH, MHRA, etc.) pharmacovigilance regulations and guidelines.
• Experience with INDs, NDAs/BLAs, and post-marketing safety surveillance.
• Proven track record of strategic leadership and cross-functional collaboration.
• Strong analytical and problem-solving skills with the ability to manage complex safety issues.
• Excellent written and verbal communication skills.

Why Join Us?

• Opportunity to contribute to cutting-edge science that makes a difference in patients’ lives.
• Collaborative and inclusive work environment.
• Competitive compensation and benefits package.
• Career growth and development in a fast-paced, innovative company.