4 дня назад
Executive Medical Director, Pharmacovigilance Risk Management (PVRM)
355 000 - 504 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Executive Medical Director, Pharmacovigilance Risk Management (PVRM) (Pharmacovigilance/Oncology): Developing and executing global product safety strategies for complex oncology clinical programs and post-marketing activities with an accent on safety surveillance, risk management, and regulatory safety deliverables. Focus on leading benefit-risk teams, interpreting safety analyses, developing aggregate reports and core safety documents, and coordinating cross-functional safety decisions.
Location: Remote; compensation is structured across U.S. geographic markets
Salary: $355,000–$504,000 annually, plus discretionary annual bonus and long-term incentives
Company
is a biotechnology and pharmaceutical company developing and commercializing oncology products.
What you will do
- Develop and execute safety strategies for complex oncology clinical development programs and marketed products.
- Create safety data analysis strategies, interpret findings, and proactively identify potential safety concerns.
- Lead safety deliverables including safety signals, aggregate reports, risk management plans, pooled safety data, regulatory filings, and clinical development documents.
- Lead cross-functional Benefit Risk Teams and co-lead benefit-risk assessments for assigned products.
- Present safety expertise to health authorities, Data Safety Monitoring Boards, investigators, and internal committees.
- Lead and mentor direct reports while collaborating with clinical development, biometrics, medical affairs, and regulatory affairs.
Requirements
- M.D. degree with at least 10 years of post-residency experience, or an equivalent combination of education and experience.
- At least 10 years of pharmacovigilance or relevant clinical research experience in a pharmaceutical or biotechnology company.
- At least 3 years of clinical experience after residency.
- Extensive knowledge of U.S. and international pharmacovigilance regulations throughout the product lifecycle.
- Strong experience in safety analysis, risk management, strategic planning, communication, and complex problem-solving.
- Experience leading projects, teams, cross-functional activities, and direct reports.
Nice to have
- Board certification for candidates in the United States.
- Pharmacovigilance experience in oncology.
- Prior project and team leadership or management experience.
Culture & Benefits
- Matrix-based collaboration across global patient safety and development functions.
- Medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, and a 401(k) plan with company contributions.
- Company stock purchase opportunities and long-term incentives.
- 15 accrued vacation days in the first year, 17 paid holidays including a December winter shutdown, and up to 10 sick days annually.
- Equipment support including dual monitors and ergonomic chairs.
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