Senior Executive – Pharmacovigilance

Pharmazone

2 - 3 years

2 - 6 Lacs

ahmedabad

Posted:1 day ago| Platform:

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Skills Required

medical writing inform medidata rave edc ich-gcp guidelines pv drug safety clinical data management pharmacovigilance ich coding psur case processing clinical research oracle clinical crf regulatory affairs argus meddra clinical trials data entry

Work Mode

Work from Office

Job Type

Full Time

Job Description

Analyses, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources
Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies
Responsible for identifying duplicate/invalid ICSRs
Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports
Perform data entry for all subject information into EDC databases as required
Perform peer review, quality review of cases as and when required
Perform peer review, quality review of all EDC data entered as required
Accountable for sending queries for clarity associated with incoming information if required
Ensure accurate and consistent coding of all the events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).
Ensure that case narrative comprises correct and appropriate safety information
Ensure that all the cases being processed with quality and submitted in a timely manner without any delays according to the service level agreement.
Contributes to safety and pharmacovigilance training programs.
Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
Training and mentoring of Pharmacovigilance Associates

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