As an Associate in Pharmacovigilance at Vantive, you will be responsible for ensuring compliance with Pharmacovigilance Quality systems, managing the adverse event (AE) and pregnancy report collection process, performing case validity assessments, and supporting safety risk management activities.
Key Responsibilities:
- PV Quality Systems:
- Comply with Baxter Pharmacovigilance Quality systems and policies.
- Ensure compliance with document management, retention, and archiving procedures.
- Complete all training requirements for the role.
- Adhere to the Business Continuity Plan (BCP).
- Perform due diligence and ICSRs intake with regards to third-party agreements.
- Case Intake:
- Manage the receipt and capture process for adverse event (AE) and pregnancy report collection in the Pharmacovigilance safety database.
- Assess and use appropriate forms and questionnaires for AE reporting.
- Perform initial assessment of case validity, seriousness, and duplication.
- Ensure all source documents are captured in the safety database.
- Determine and collect follow-up information related to ICSRs.
- Perform ongoing tracking and quality checks of AE cases.
- Safety Risk Management Activities:
- Support implementation of risk minimization measures.
- Perform surveillance for new potential safety information and escalate as needed.
- Other Responsibilities:
- Escalate requests from Regulatory Authorities to the Qualified Officer in charge.
- Update the Pharmacovigilance Officer in charge of all pharmacovigilance activities and safety issues.
