Pharmacovigilance Associate, Pharmacovigilance Operations will work on projects and processes that ensure the strategies of the department are executed within global safety legislation and requirements. To do this, the PV Associate will be responsible for activities within PV Operations and Compliance, as well as support Medical Safety, as needed.
- Provide support for oversight and review of vendor activities, including case processing, and aggregate reports. This may include the support of monitoring compliance, effective communication and implementation of corrective and preventive actions, as needed.
- Participates in the quality review of SAEs and SUSARs following data entry by
- Assists in aggregate report processes. Assists cross-functional teams with PV and safety activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across clinical trials.
- Assists in reconciliation activities to ensure reporting of all adverse event data.
- Actively participates in
cross functionalprojects that develop and support strong cross-functional relationships and communication.
- Maintains knowledge of adverse event reporting process and safety system and contributes to the development, improvement
andstandardization of new processes and methods.
- Contributes to projects which involve the implementation of new processes and methods.
- Undertakes activities necessary to be inspection ready.
- Supports signaling, medical safety
andsafety management teams, as needed.
- Bachelor’s degree in nursing, pharmacy, or other life sciences required. Master’s degree, preferred.
- 1-2 years of Drug Safety and Pharmacovigilance experience.
- Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance required.
- Oncology experience preferred.
Job Location: Cambridge, MA
Please send resumes to email@example.com