Safety and Pharmacovigilance Specialist
3 weeks ago
Job Summary
We are seeking a highly skilled Safety & Pharmacovigilance Specialist to join our team at Beacon Hill Life Sciences - Boston. As a key member of our clinical research team, you will be responsible for performing various tasks in support of clinical research, including adverse event analysis and processing, serious adverse event reconciliation, and preparation of IND safety reports for submission to the FDA.
Responsibilities
- Perform adverse event analysis and processing, including serious adverse event reconciliation
- Prepare IND safety reports for submission to the FDA
- Conduct safety document or data analysis
- Provide clinical trial site support
Requirements
- M.D. or D.O. from an accredited institution
- Infectious disease and/or oncology subspecialty highly preferred
- Knowledge of GCP and ICH guidelines
- Drug development/clinical trial experience essential
- Knowledge of CTC and/or MedDRA coding preferred
- Experience leading clinical and cross-functional teams is a plus
- Excellent oral, written, presentation, and computer skills
- 3+ years of pharmaceutical or biotech industry or academic experience
Company Description
Beacon Hill Life Sciences - Boston is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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