Director, Pharmacovigilance

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

The Director of Pharmacovigilance (PV) will provide strategic leadership and oversight of global drug safety activities, ensuring compliance with regulatory requirements across clinical and post-marketing programs. This role drives the integrity and timely reporting of safety data, performs signal detection, and contributes to risk management and medical safety strategy. You will collaborate with cross-functional teams including Regulatory Affairs, Clinical Development, and Data Management to optimize PV operations, support regulatory submissions, and enhance patient safety processes. Success in this position requires deep scientific expertise, strong leadership, and the ability to guide teams and vendors while maintaining compliance with global regulations. The role offers a partially remote work environment and involves interactions with global health authorities.

• Accountabilities:
• Lead global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting.
• Provide medical and technical support for clinical project teams, ensuring accurate safety evaluation and timely adverse event reporting.
• Oversee safety data integrity across clinical and post-marketing programs, ensuring compliance with internal SOPs and global regulatory standards.
• Collaborate with CROs, vendors, and cross-functional teams to manage safety reporting, reconcile data, and review clinical and safety databases.
• Contribute to preparation and review of regulatory submissions, periodic safety reports, and study documents (e.g., protocols, Investigator’s Brochures, clinical study reports).
• Lead Safety Management Team meetings, perform signal detection, and provide proactive safety assessments.
• Develop, author, and maintain SOPs, Safety Management Plans, and safety agreements with partners and vendors.
• Represent the company in communications with FDA and other global regulatory authorities for safety-related inquiries.
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• Requirements:
• MD required, with a minimum of 10 years of pharmacovigilance/drug safety experience in the pharmaceutical or biotechnology industry.
• Expert understanding of global PV practices, U.S. and international PV regulations, GCP, and ICH guidelines.
• Proficiency with validated safety databases and coding dictionaries (e.g., MedDRA, WHO Drug).
• Experience authoring and overseeing aggregate safety reports and leading safety strategy initiatives.
• Strong scientific, analytical, and problem-solving skills.
• Exceptional written and verbal communication skills with the ability to present complex safety data to diverse audiences.
• Proven leadership, collaboration, and stakeholder management abilities.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and PV safety tools.
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• Benefits:
• Stock options
• 401(k) plan with 4% company match, no vesting schedule
• Medical, dental, and vision insurance
• Company-paid long-term and short-term disability insurance
• Company-paid life insurance
• 23 days paid time off (PTO)
• 10 company-designated holidays plus 2 floating holidays
• Paid parental leave

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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