Senior Medical Director, Pharmacovigilance, Risk Management

 

Senior Medical Director, Pharmacovigilance, Risk Management 

Location: Alameda, CA or King of Prussia, PA

Position Overview:

The Senior Medical Director oversees medical safety for products during clinical development and post-marketing. This role leads safety strategy, signal management, and risk management for assigned products. It involves cross-functional collaboration and escalation of safety findings to senior governance.

Key Responsibilities:

• Lead safety strategy for assigned products, managing aggregate data and signal detection.
• Direct the Benefit Risk Team, escalating safety updates to the Benefit Risk Committee.
• Develop and maintain Company Core Safety Information and ensure risks are communicated in product labels.
• Provide expertise in pharmacovigilance and risk management for internal and external stakeholders.
• Manage safety strategy for clinical and regulatory documents, and respond to regulatory inquiries.
• Lead proactive safety data reviews and oversee global periodic safety reports.
• Present safety data to Health Authorities and other key stakeholders.
• Develop risk management strategies and co-lead benefit-risk assessments.

Qualifications:

• M.D. degree required; Board Certification preferred.
• Minimum 8 years of experience post-residency, with at least 3+ years of clinical experience.
• 7+ years in pharmacovigilance, preferably in oncology.
• Strong knowledge of US and EU pharmacovigilance regulations.
• Excellent organizational, communication, and interpersonal skills.
• Experience with cross-functional project management and mentoring junior team members.

Compensation:

• Base pay range: $270,500 - $384,000 annually, adjusted for geographic region and experience.
• Comprehensive benefits package, including 401k, medical, dental, vision, and long-term incentives.
• Eligibility for discretionary bonus or sales-based incentive plan.

Disclaimer:

This job description outlines the general nature and level of work expected. It is not an exhaustive list of all duties, responsibilities, or qualifications required.

Equal Opportunity Employer:

We do not discriminate based on race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any other protected class.