Pharmacovigilance - Aggregate Reporting - Lead
Full Time
AGGREGATE REPORTING
PHARMACOVIGILANCE
QUALITY AUDIT
Job description
Job Title : Pharmacovigilance - Aggregate Reporting -
Manager/Senior Manager
Responsible 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 Skills
Pharmacovigilance
Aggregate Reporting
RMP and Signal detection / Management
Skills Required
Pharmacovigilance - Aggregate Reporting - Lead
Pharmaceuticals
MBBS
Full Time, Permanent
Key Skills
- AGGREGATE REPORTING
- PHARMACOVIGILANCE
- QUALITY AUDIT
Other Information
GO/JC/1322/2025
Sangeetha Tamil
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