Pharmacovigilance - Aggregate Reporting - Lead

Golden Opportunities

8 - 10 years

40 Lacs

hyderabad

Posted:9 hours ago| Platform:

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Skills Required

pharmacovigilance quality audit medical risk assessments aggregate reporting risk management plananing risk management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities:

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

Contact Person: Sangeetha Tamil

Email ID: sangeetha@gojobs.biz

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