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. This role offers a unique opportunity to lead global pharmacovigilance operations within a pioneering biotechnology environment. The Director, Pharmacovigilance, will ensure the safety of clinical and post-marketing products through expert oversight of adverse event reporting, signal detection, and risk management. The position requires cross-functional collaboration with clinical development, regulatory affairs, and data management teams to maintain compliance with global regulatory standards. The successful candidate will contribute to medical safety strategy, support regulatory submissions, and drive continuous improvement of PV systems and processes. This position provides the ability to make a meaningful impact on patient safety and support innovative therapies that transform healthcare. The role is remote within the continental U.S., offering flexibility while leading high-stakes, global safety initiatives. Accountabilities:

• Lead global pharmacovigilance operations, including case management, vendor oversight, and aggregate safety reporting.
• Provide medical and technical support for clinical projects, ensuring accurate evaluation of adverse events and study-related safety data.
• Oversee safety submissions to global health authorities, including PBRERs, DSURs, PADERs, and annual reports.
• Collaborate with cross-functional teams to develop risk management plans, post-marketing safety studies, and clinical documentation.
• Drive inspection readiness, respond to health authority inquiries, and ensure regulatory compliance across all PV activities.
• Develop and maintain standard operating procedures (SOPs), safety management plans (SMPs), and partner/CRO agreements.
• Organize and lead Safety Management Team (SMT) meetings to assess emerging safety concerns and ensure timely communication.

Requirements:

• MD degree required with a minimum of 10 years of pharmacovigilance or drug safety experience in biotech or pharmaceutical industries.
• Deep knowledge of global PV regulations, GCP, ICH guidelines, and adverse event reporting requirements.
• Expertise in safety databases and coding dictionaries such as MedDRA and WHO Drug.
• Proven ability to author and oversee aggregate safety reports and conduct proactive safety evaluations.
• Strong leadership, collaboration, and stakeholder management skills with experience guiding cross-functional teams.
• Exceptional analytical, written, and verbal communication skills for presenting complex safety data to diverse audiences.
• Proficiency in Microsoft Office Suite and PV data management tools.

Benefits:

• Stock options and long-term growth opportunities.
• 401(k) plan with 4% match and no vesting schedule.
• Comprehensive medical, dental, and vision insurance coverage.
• Company-paid short-term and long-term disability insurance and life insurance.
• 23 days of paid time off, 10 company holidays, and 2 floating holidays.
• Paid parental leave policies and flexible remote work options.

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. #LI-CL1 Apply tot his job Apply To this Job