Vice President, Pharmacovigilance
$300,000–$420,000 year
On-site · Remote, Oregon, United States
Job Summary
Lead global pharmacovigilance and drug safety strategy across the product lifecycle, providing medical oversight for safety data and benefit-risk assessments; oversee case processing, aggregate reporting, signal detection, and risk management; guide regulatory documentation safety sections (BLA/MAA/NDA) and communication to patients, healthcare providers, and authorities; build and manage an inspection-ready pharmacovigilance team; ensure compliance with GVP/GCP and corporate quality standards; collaborate across Clinical Development, Regulatory Affairs, QA, Medical Affairs, and external stakeholders; provide medical guidance on safety data from pre- and post-marketing activities; require MD with board certification and 10+ years in pharmacovigilance, including leadership; offer base pay range of $300,000–$420,000 with incentives and equity.
Required Qualifications
- MD and Board Certification in a relevant therapeutic area
- 10+ years of experience in pharmacovigilance leadership roles, including at least 3 years in senior or executive leadership
- In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, EMA, and other relevant regulatory requirements
- Demonstrated success in establishing or scaling post-marketing pharmacovigilance systems and teams within a small to mid-sized company
- Experience with evaluation, implementation and oversight of pharmacovigilance systems and processes, including developing quality and compliance metrics
- Experience mentoring all levels of staff to further develop skills, provide opportunities for growth, and ensure a professionally challenging environment that fosters retention
- Demonstrated strong written and verbal communication skills
- Proven mindset of proactive continuous improvement
- Efficient worker with demonstrated ability to collaborate cross-functionally to achieve results
- Strong commitment to ethical standards
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