Pharmacovigilance Compliance

Division
- PHARMACOVIGILANCE
- Job posted on
- Jan 10, 2023
- Employee Type
- P-P8-Probationer-HO Executive
- Experience range Range (Years)
- 2 years - 7 years
- Preparation and review of SOPs/WIs/Policies/Conventions.
- Preparation, review and maintenance of safety data exchange agreement/pharmacovigilance agreement/any other agreement, as applicable.
- Ensure timely processing and submission of ICSRs as per applicable SOPs/WIs/agreements and regulatory requirement.
- Review of Periodic Safety Update Report (PSUR)/Periodic Adverse Drug Experience Report (PADER)/Risk Management Plan (RMP)/other periodic reports and ensure their timely submission as per regulatory requirement.
- Ensure timely sharing of the reconciliation report with concerned stake holder(s) as per applicable procedure/agreement.
- Review of all logs/trackers/forms related to pharmacovigilance activities, as applicable.
- Monitoring overall compliance of pharmacovigilance activities.
- Identify deviation(s), if any and implement CAPA as required.
- Conduct internal audit(s)/vendor qualification audit(s)/other pharmacovigilance audit(s), as assigned.
- Handling of all queries from concerned stake holders and/or regulatory agency, as required.
- Maintain awareness with respect to new regulations affecting pharmacovigilance activities.
- Impart pharmacovigilance training to team members/concerned stake holders, as applicable.
- Ensure that all pharmacovigilance related documents are archived and handled as per applicable procedure.