Job Title

Executive / Assistant Manager- Pharmacovigilance- Aggregate ReportingExperience: 7 - 12 yearsQualification : B Pharm / M PharmRESPONSIBILITIES- 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 countryspecific 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.