Pharmacovigilance - Aggregate Reporting - Lead - GO/JC/1322/2025

Job Title : Pharmacovigilance - Aggregate Reporting - Manager/Senior ManagerResponsible for coordinating Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO) related activities (including but not limited to PSUR writing & medical review, handling of requests received from Central & Local Regulatory Affairs and PV departments) within respect of timelines and any other related task.Responsible for coordinating Risk Management Plans (RMP) related activities (including but not limited to collection of data, RMP writing and medical review, handling requests received from central or local regulatory affairs and PV department) within timely manner.Responsible for Signal Management related activity (including signal detection by company methodology, medical review of signaling reports, communication and escalation to CPSC).Provides safety input into Medical Risk Assessments (MRAs), drives the process from SST and develops and follows-up the quality issues having safety implications.Writing & update of Standard Operating Procedures (SOP).Assists or oversees any other project where PV is involved, as deemed necessary.Must Have SkillsPharmacovigilanceAggregate ReportingRMP and Signal detection / Management

Skills Required

RolePharmacovigilance - Aggregate Reporting - LeadIndustry TypePharmaceuticalsFunctional AreaRequired Education MBBSEmployment TypeFull Time, PermanentKey Skills

• AGGREGATE REPORTING
• PHARMACOVIGILANCE
• QUALITY AUDIT
  

Other Information
Job CodeGO/JC/1322/2025Recruiter NameSangeetha Tamil