Officer - Pharmacovigilance

Role & responsibilities

Job Responsibilities : Literature Screening

1. Review of the world wide scientific and medical literature in accordance with company-controlled documents (e.g. SOPs, WIs, Guide) relevant regulations and guidelines.

2. Maintain permanent organized documented records of all literature safety reports received and reported.

3. Additional Responsibilities: Preparation, revision, review of SOPs, Wls, templates, guide and guidance training documents.

4. Communication of urgent safety issues to Line manager.

5. Ensure communication with all relevant people is of a high professional standard, and that records of both internal and external communication are maintained.

6. Support to be given for performing case processing including data entry, Drug coding, MedDRA coding, Listedness, assessment for expediting, narrative writing of ICSR in accordance with companys controlled documents (e.g. SOPs, WIs, Guide).

7. Basic entry of literature cases received from Pubmed

8. Creating safety ids by uploading and importing received files or manually as and when required.

9. Perform duplicate search.

10. Initiating received cases in database by creating safety ID's.

11. Manage tracking of all cases received from regulatory authorities.

12. Weekly reconciliation of regulatory cases with source of receipt.

13. Preparation, revision, reviews of SOPs, Wls, templates, guide and guidance training documents.

14. Communication of urgent safety issues to Line manager and QPPV.

15. Ensure communication with all relevant people of a high professional standard, and that records of both internal and external communication are maintained.

Job Responsibilities: Basic Entry

1. Basic entry of regulatory cases received from Regulatory authorities

2. Creating safety ids by uploading and importing received files or manually as and when required

3. Perform duplicate search

4. Initiating received cases in database by creating safety ID's

5. Manage tracking of all cases received from regulatory authorities

6. Weekly reconciliation of regulatory cases with source of receipt

7. Receipt of regulatory cases from applicable regulatory authorities

8. Preparation, revision, reviews of SOPs, Wls, templates, guide and guidance training documents

9. Communication of urgent safety issues to Line manager and QPPV

10. Ensure communication with all relevant people of a high professional standard, and that records of both internal and external communication are maintained

11. Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Companys global Pharmacovigilance requirements

12. Deliver training to new joiner and team as per requirement

13. Work with the ICSR team leader to escalate issues or tasks outside the normal scope of work

14. Support group leader for timely submission of ICSR in order to achieve 100% regulatory compliance

15. PV-Case Processing

16. Case processing including data entry, Drug coding, MedDRA coding, Listedness, Causality assessment, assessment for expediting, narrative writing of ICSR in accordance with Companys controlled documents (e.g. SOPs, WIs, Guide) relevant regulations and guidelines.

Job Responsibilities: MICC

1. Ensure that Medical enquiry e-mail box, fax machine, phone and postage are checked daily for Adverse events/Medical enquiry/Product enquiry.

2. Tracking and Handling of medical inquiry in accordance with company’s-controlled documents (e.g. SOPs, Wls, Guide).

3. Logging and updating of enquiry in Medical Information database.

4. Safety ID creation in global safety database.

5. Assist designated medical reviewer for follow up of all medical enquiry on and communication of enquiry response in liaise with designated medical reviewer.

6. Reconciliation of medical enquiries received from clients and their affiliates, business partners.

7. Reconcile and acknowledge adverse events/product complaints emails in accordance with safety data exchange as per SDEA and PMP.

8. SDEA, SOP, & WI preparation.

9. Perform additional tasks/responsibilities as assigned/delegated by the Team lead/Manager.

10. Assisting with the preparation of the audit/inspection and participating in the audit/inspection when appropriate.

11. Preparation and communication of enquiry response in liaise with designated medical reviewer.

Preferred candidate profile

• Qualification : M.Pharm / Pharm D.
• Experience : 0 to 2 years