Pharmacovigilance Executive

Executive / Assistant Manager
- Pharmacovigilance
- Aggregate Reporting

Experience:

7 - 12 years

Qualification : B Pharm / M Pharm

RESPONSIBILITIES

- Oversight of all aggregate reporting activities including experience in people management/ project handling/task assignment.
- Prepare and maintain PV documents, standard operating procedures (SOPs) and work instruction (WI).
- Train the PV team and relevant stakeholders on SOPs and Wis
- Organize trainings to corporate office staff and new joiners, Manufacturing plants and other vendors if applicable.
- Prepare and review Aggregate reports [Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs)] and Risk Management Plans (RMPs) or any other document as requested by regulatory authorities.
- Submit aggregate reports to regulatory authorities.
- Preparation and maintenance of PADER and PBRER calendar.
- Prepare PV agreements (SDEA) with partner companies or service providers.
- Ensure PV compliance in accordance with company SOPs and regulatory requirements.
- Select, audit, and provide oversight of service providers involved in Pharmacovigilance (PV) activities, including conducting regular meetings.
- Provide accurate and satisfactory responses to medical information queries.
- Support the Medical Affairs team in responding to enquiries received from PV sources.
- Perform literature screening and maintain records of literature searches.
- Complete and verify Argus Access forms in the capacity of a supervisor
- Compare Product Characteristics (SmPC) and Patient Information Leaflet (PIL) summaries.
- Prepare Health Hazard Evaluation (HHE) reports as required.
- Prepare and maintain the Pharmacovigilance System Master File (PSMF) in line with regulatory expectations.
- Monitor regulatory authority websites to identify, assess, and document safety updates, recommendations, and regulatory actions that may impact product safety or compliance.

DESIRED SKILLS

- Strong understanding of international and country specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive etc.)
- Excellent verbal/written communication skills
- Works effectively and cooperatively as part of a team
- Good attention to detail and decision-making skills.
- Strong interpersonal skills and the ability to work in dynamic work environments.