Job Posting:
Position: Associate, Pharmacovigilance (PV)
Organization: Baxter (Vantive)
Location: Gurgaon
Salary: ₹25,000 – ₹35,000 /month
Experience: 1 to 12 Years
Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences
About the Company:
Vantive is a new company building on Baxter’s nearly 70-year legacy in acute therapies and dialysis. As a standalone company, Vantive aims to provide best-in-class care for kidney care patients and other vital organ support. The separation from Baxter is subject to the satisfaction of customary conditions.
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.
How to Apply:
If you are passionate about ensuring safety and compliance in Pharmacovigilance, apply today and join our team in Gurgaon!