This contractor role focuses on medical review and interpretation of safety data for pharmaceutical products, including individual case safety reports, signal detection, and benefit-risk assessments. The physician also supports aggregate safety reporting, regulatory submissions, and safety-related documentation across clinical trial and post-marketing programs. Collaboration with clients, regulatory authorities, and internal pharmacovigilance teams is a core part of the work.
Key Responsibilities
- Conduct medical review of individual case safety reports and provide medical assessment statements.
- Review and interpret clinical trial and post-marketing safety data.
- Perform benefit-risk analyses and support aggregate safety assessments.
- Support signal detection, evaluation, and verification activities.
- Assist with pharmacovigilance compliance activities and Qualified Person for Pharmacovigilance support as needed.
- Participate in client safety meetings and discussions with safety monitoring boards and regulatory authorities.
- Draft, review, and refine medical sections of periodic safety reports, product labeling, and regulatory safety documents.
- Assist with risk management plans and risk evaluation and mitigation strategies when required.
Required
- MD, DO, or equivalent medical degree.
- Active medical license in good standing, or equivalent unlicensed physician background with no record of board disciplinary action.
- At least 5 years of pharmacovigilance, clinical healthcare provider, or equivalent relevant experience.
- Experience in the pharmaceutical industry or other drug safety-related roles.
- Knowledge of pharmacovigilance regulations and compliance requirements.
Preferred
- Board certification in a therapeutic area relevant to client programs.
- Training or degree in epidemiology.
- Experience with Microsoft Office applications.
- Experience with content management systems.
Benefits & Perks
- Remote work within the United States.
- Contractor employment arrangement.
- Opportunity to support client programs across global pharmacovigilance and drug safety activities.
- Collaborative work with internal teams, clients, and regulatory authorities.