Director, Pharmacovigilance

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Pharmacovigilance in United States.

We are seeking a highly experienced Director of Pharmacovigilance to lead global drug safety operations and ensure regulatory compliance across clinical and post-marketing programs. This role provides strategic oversight of safety data integrity, risk management, and signal detection, while collaborating closely with Regulatory Affairs, Clinical Development, and Data Management teams. The ideal candidate will drive continuous improvement of pharmacovigilance systems, contribute to medical safety strategies, and support regulatory submissions for innovative therapeutics. This position is ideal for a hands-on leader with strong analytical, medical, and regulatory expertise who thrives in a collaborative, cross-functional environment.

• Lead global pharmacovigilance operations, including case management, vendor oversight, aggregate reporting, and safety monitoring for clinical and post-marketing programs.
• Provide medical and technical support to clinical project teams to ensure successful design, execution, and safety evaluation of development plans.
• Oversee and review individual case safety reports (ICSRs), aggregate safety reports, and analyses of similar events (AOSE).
• Drive regulatory compliance, including preparation and submission of periodic safety reports (PBRERs, DSURs, PADERs, Investigator’s Brochures) within required timelines.
• Collaborate with CROs, Data Management teams, and internal stakeholders to reconcile adverse events and ensure database integrity.
• Lead interactions with global health authorities, respond to safety-related inquiries, and maintain inspection readiness.
• Develop, implement, and maintain standard operating procedures (SOPs), safety management plans (SMPs), and risk management strategies.

• Doctor of Medicine (MD) required with a minimum of 10 years of pharmacovigilance/drug safety experience in the pharmaceutical or biotechnology industry.
• Expert knowledge of global PV practices, regulatory frameworks, GCP, and ICH guidelines.
• Experience authoring and reviewing aggregate safety reports and proactively managing safety signals.
• Proficient in validated safety databases and coding dictionaries (MedDRA, WHO Drug).
• Strong analytical, communication, and leadership skills with the ability to present complex safety data to diverse stakeholders.
• Demonstrated experience collaborating cross-functionally with Regulatory Affairs, Clinical Development, and Data Management teams.
• Proficiency in Microsoft Office Suite and safety data management tools.

• Stock options and 401(k) plan with 4% match and no vesting schedule.
• Comprehensive medical, dental, and vision insurance.
• Company-paid life insurance and long-term/short-term disability coverage.
• Paid time off: 23 PTO days, 10 company-designated holidays, plus 2 floating holidays.
• Paid parental leave policies.
• Flexible partial remote work arrangement.

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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