Drug Safety Manager – US

Role: Director of Pharmacovigilance, Drug Safety

Location: Remote (USA)
Department: Drug Safety / Pharmacovigilance
Reports To: VP, Clinical Development / Chief Medical Officer

About the Company

We are a growing biotechnology company focused on developing innovative therapies for serious and unmet medical needs. Our mission is to improve patient lives through breakthrough science and a strong commitment to innovation, collaboration, and excellence.

Join a passionate team working at the forefront of biotech innovation.

About the Role

We are looking for a Director of Pharmacovigilance (PV) to lead all global safety activities for our development and marketed products. This role is both strategic and operational, covering every stage of the product lifecycle.

You will oversee safety monitoring systems, ensure compliance with global regulations, and guide cross-functional teams on safety-related matters.

Key Responsibilities

Safety Strategy & Leadership

• Lead the design and execution of global pharmacovigilance programs.

• Set up and manage PV systems across clinical and commercial stages.

• Provide expert input on clinical development plans and product labeling.

Adverse Event Oversight

• Oversee the collection, evaluation, and reporting of adverse events.

• Ensure timely submissions of safety reports (SUSARs, PSURs, DSURs, etc.) to regulatory bodies.

Regulatory Compliance

• Stay current with FDA, EMA, ICH, and other global PV regulations.

• Maintain inspection-readiness and lead preparation for audits and regulatory reviews.

Team & Vendor Management

• Build and mentor a high-performing PV team.

• Manage vendor/CRO relationships, including contracts and quality oversight.

Risk Management & Signal Detection

• Lead risk management activities, including Risk Management Plans (RMPs) and REMS programs.

• Monitor safety signals and support data-driven decisions on risk mitigation.

Cross-functional Collaboration

• Partner with Clinical Development, Regulatory, Medical Affairs, and QA teams.

• Represent PV in internal safety review committees and external meetings.

Qualifications

• Advanced degree (MD, PharmD, PhD, or equivalent); MD preferred.

• At least 10 years of pharmacovigilance experience in biotech or pharma.

• 3–5 years in a leadership role overseeing PV teams or systems.

• Strong knowledge of U.S. and global PV regulations and safety reporting.

• Experience with INDs, NDAs, BLAs, and post-marketing surveillance.

• Excellent communication, leadership, and problem-solving skills.

Why Join Us?

• Work on therapies that transform patient lives.

• Join a collaborative, forward-thinking, and inclusive culture.

• Enjoy competitive pay and benefits.

• Grow your career in a fast-paced, science-driven environment.