This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Drug Safety Physician in the United States.
This senior medical leadership role plays a critical part in advancing the safety and development of innovative therapeutic programs. You will oversee medical review, safety surveillance, and pharmacovigilance activities for clinical-stage assets, ensuring compliance with global regulatory standards. The role involves evaluating individual case safety reports, assessing aggregate safety data, contributing to risk management strategies, and supporting clinical development planning. You will collaborate with cross-functional teams, participate in safety committee meetings, and help shape pharmacovigilance processes to ensure the highest quality and timely reporting. Your work will directly impact patient safety and drug development decisions, combining scientific expertise with strategic oversight in a dynamic, fast-paced environment.
Accountabilities:- Lead triage and medical review of individual case safety reports (ICSRs) and oversee expedited safety reporting processes.
- Participate in safety surveillance, signal detection, and risk management planning across clinical development programs.
- Contribute to clinical trial document review, including protocols, investigator brochures, and informed consent forms, ensuring pharmacovigilance compliance.
- Support the preparation and review of aggregate safety reports, such as DSURs, and provide medical input for regulatory submissions.
- Collaborate with cross-functional teams and co-lead safety committee meetings, fostering consistent and high-quality medical oversight.
- Develop and maintain state-of-the-art pharmacovigilance processes, standard operating procedures, and best practices.
- Provide strategic safety guidance on benefit-risk evaluation, clinical development plans, and emerging safety signals.
Requirements:
- MD or equivalent medical degree with 6+ years of clinical development drug safety or medical review experience in biotech or pharmaceutical settings.
- Proficiency with global safety databases, such as Argus, and experience in medical review and pharmacovigilance operations.
- Strong knowledge of global regulatory requirements for pharmacovigilance (FDA, EMA, and other applicable authorities).
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable strategies.
- Demonstrated ability to communicate effectively and collaborate across functions and teams.
- Strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
- Commitment to high-quality, compliant, and ethical pharmacovigilance practices.
Benefits:
- Competitive base salary of $280,000–$315,000, with performance-based incentives.
- Comprehensive health, dental, and vision insurance plans.
- Retirement and welfare benefits.
- Unlimited paid time off and company-wide shutdowns for holidays.
- Flexible remote work arrangements with in-person collaboration for key meetings.
- Professional development and learning opportunities in a dynamic clinical research environment.
- Exposure to cutting-edge therapeutics and participation in shaping innovative drug safety strategies.
How Jobgether works:
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!
Why Apply Through Jobgether?
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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