Associate Director, 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 Associate Director, Pharmacovigilance Operations will be responsible for activities within PV Operations and Compliance, as well as support Medical Safety, as needed.
- Participates in the review and execution of PV Operations safety data collection and processing strategy across programs.
- Provides oversight and review of vendor activities, including case processing, and aggregate reports. Oversight activities include monitoring compliance, effective communication and implementation of corrective and preventive actions, as needed.
- Actively participates in the quality review of SAEs and SUSARs following data entry by vendor.
- Responsible for managing aggregate report processes to ensure timeliness, completeness and quality.
- Responsible for managing cross-functional activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across clinical trials.
- Participates in the creation and dissemination of appropriate safety reporting language in clinical trial key documents.
- Accountable for reconciliation activities to ensure reporting of all adverse event data.
- Actively participates in and manages cross functional projects 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 and standardization 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 and safety management teams.
- Other duties as assigned.
- Bachelor’s degree in nursing, pharmacy, or other life sciences required. Master’s degree, preferred.
- 5-7 years of Drug Safety and Pharmacovigilance experience.
- Vendor management experience.
- Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance required.
- Experience using ARISg, Argus or other Safety Database applications.
- Oncology experience preferred.
Job Location: Cambridge, MA
Please send resumes to email@example.com
Equal Opportunity Employer
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