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Pharmacovigilance Associate II
2-3 years
Bangalore / Bengaluru
1 vacancy
Pharmacovigilance Associate II
Watson Pharama
posted 1d ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
opportunity
How you ll spend your day
Your experience and qualifications
- This role supports the aggregate reports preparation process, by generating and collecting required data to support writers in report preparation along with authoring relevant sections of the assigned reports. This role also supports the aggregate reports preparation process providing QC.
How you ll spend your day
- Generate required reports (line listings, summary tabulations) from PV database and BI platforms for all assigned reports).
- Collecting/assimilating data to support writers in report preparation along with authoring relevant sections for all assigned reports.
- Ensure the cases within the PV database is complete with accurate information in all data fields required for preparation of the reports by promptly raising correction requests to relevant teams and following up until resolution in line with applicable control procedural documents.
- Assess and perform case separation per formulation / dose / dosage / indication as applicable prior to report generation using BI platform.
- Review/ perform QC of the data generation, collection and authoring for assigned reports.
- Act as topic lead for selected parts of the process/projects.
- Coach, develop and mentor junior staff within the team.
- Drafting responses to queries from stakeholders and requests from regulatory agencies, as required.
- Author and maintain training documents/working procedures under the scope of the team.
- Making sure assigned periodic reports support activities are performed in line with all applicable working procedures.
- Collaborative working relationships with peers, writers and other functions within organization unit and in Teva.
- Any other task assigned by direct manager.
Your experience and qualifications
- University degree [BDS, BAMS, BHMS, Pharm.D, M.Pharm (Pharmacy Practice/ Pharmacology/Regulatory affairs)]
- 2-3 years of experience in Pharmacovigilance (Medical writing and/or ICSR/case processing including clinical trials). Previous experience in preparation of periodic reports is desirable.
Employment Type: Full Time, Permanent
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Strict timing
Monday to Friday
Within city
Day Shift
Watson Pharama Benefits
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