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Pharmacovigilance/safety Associate
4 months ago
Pharmacovigilance/Safety Associate
Responsibilities of the Pharmacovigilance Associate include but are not limited to:
- Review of medical records for serious adverse event reporting
- Writing clinical narratives and FDA MedWatch form 3500 (if applicable)
- Entering data into Safety Database
- Working with other safety personnel in cross checking cases as a quality control mechanism
- Reconciliation of clinical database entries with safety data.
- Clinical Data listing review with project team
- Liaise with medical monitor for safety review/finalization of serious adverse events.
- May participate in medical and concomitant medication coding review
- Effective communication between site staff, sponsor, internal staff members
- Participate in project team meetings
- Knowledge of FDA/GCP/ICH regulatory requirements
- Knowledge of Excel, Word, and Adobe
- Other special projects as assigned by Senior Management
Background in nursing or other clinical field required. At least 2 years of Safety experience required.
**Job Types**: Full-time, Contract
Pay: $70,000.00 - $85,000.00 per year
**Benefits**:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Ability to Relocate:
- Boston, MA 02111: Relocate before starting work (required)
Work Location: Hybrid remote in Boston, MA 02111
