Golden Opportunities
Website:
gojobs.biz
Job details:
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
RolePharmacovigilance - Aggregate Reporting - Lead
Industry TypePharmaceuticals
Functional Area
Required Education MBBS
Employment TypeFull Time, Permanent
Key Skills
- AGGREGATE REPORTING
- PHARMACOVIGILANCE
- QUALITY AUDIT
Other Information
Job CodeGO/JC/1322/2025
Recruiter NameSangeetha Tamil
Click on Apply to know more.