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Barrington James is partnered with a large research consultancy looking to bring on board a Pharmacovigilance Head on a part time contract.
Responsibilities would include:
- Lead the company’s drug safety and pharmacovigilance strategy.
- Oversee collection, evaluation, and reporting of side effects (adverse events).
- Manage safety reports (e.g., PSURs, DSURs, RMPs) for health authorities like FDA and EMA.
- Detect and assess safety signals and take action if needed.
- Work with other departments (Clinical, Regulatory, Medical, Quality) on product safety.
- Lead safety-related meetings and decision-making groups.
- Manage relationships with PV vendors and ensure high-quality work.
- Prepare for and lead regulatory inspections and audits.
- Build and lead a strong PV team
Requirements:
- Must have managed FDA interactions
- Familiar with setting up and running PV departments
- Experience in ensuring regulatory compliance
This is a fully remote position but candidates would need to be based in the US
Seniority level
Seniority level
Director
Employment type
Employment type
Contract
Job function
Job function
Science, Consulting, and ResearchIndustries
Pharmaceutical Manufacturing, Research Services, and Biotechnology Research
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