Officer - Medical Information, Pharmacovigilance

Key Highlights of Our Pharmacovigilance Services:

• Global Expertise: With a dedicated team of over 160 professionals, including physicians and pharmacovigilance specialists, we have successfully supported more than 265 clinical trials across diverse therapeutic areas.
• Robust Framework: Our well-established pharmacovigilance framework guarantees thorough safety monitoring and adherence to regulatory requirements, empowering drug safety and enhancing patient well-being.
• Advanced Technology: We utilize an automated web-based pharmacovigilance solution compliant with international standards, which streamlines processes and ensures accuracy in data handling.

Role & responsibilities

1. Daily Checks: Ensure that the medical inquiry email box, fax machine, phone, and postal mail are checked daily for adverse events, medical inquiries, and product inquiries.
2. Tracking and Handling: Manage medical inquiries in accordance with the companys controlled documents (e.g., SOPs, WIs, Guides).
3. Database Management: Log and update inquiries in the Medical Information database.
4. Safety ID Creation: Create Safety IDs in the global safety database.
5. Support Medical Reviewers: Assist designated medical reviewers with follow-ups on all medical inquiries and communicate responses in coordination with them.
6. Reconciliation of Inquiries: Reconcile medical inquiries received from clients, affiliates, and business partners.
7. Acknowledgment of Events: Reconcile and acknowledge adverse events/product complaints emails as per Safety Data Exchange Agreement (SDEA) and Product Management Plan (PMP).
8. Documentation Preparation: Prepare SDEA, SOPs, and Work Instructions (WIs).
9. Additional Responsibilities: Perform additional tasks as assigned by the Team Lead or Manager.
10. Audit Support: Assist in preparing for audits/inspections and participate when appropriate.
11. Response Communication: Prepare and communicate inquiry responses in coordination with designated medical reviewers.

Preferred candidate profile

• B. Pharm, M. Pharm, Pharm D (Any, Preferably in Pharmacology), Nursing, BDS.
• 0-1 yrs experience candidate with excellent communication can apply.
• Shift Timing - 1 pm to 10 pm / 2 pm to 11 pm.
• Male candidate preferred.
• Work from office role.