Vacancy for ICSR case processing (Pharmacovigilance) at ClinChoice
About the job
- Perform duplicate search, intake, and triage of the received source documents such as Spontaneous, Literature, Regulatory and clinical trials as per agreed timelines.
- Possess thorough knowledge of regulatory updates. Awareness and understanding of relevant GVP modules.
- Perform data entry which includes but not limited to causality, labeling and seriousness assessments, MedDRA coding for all the events, medical history, and laboratory findings, and drafting narratives.
- Complete the case processing activities within the stipulated time by prioritizing allocated cases in accordance with service level agreement and regulatory timelines and contribute to the management of daily workflow.
- Raise follow-up queries, as necessary, with appropriate documentation in the safety database or per applicable procedures within defined timelines.
- Ensure completeness and accuracy of the ICSR incorporating the medical review feedback comments and finalize the case as per service level agreements and regulatory timelines.
- Update the applicable project specific trackers in time.
- Review all follow-up information and identify relevant information and update the same in the safety database or per applicable procedures. etc.,
- Be aware of and comply with the PIMS Policy and GDPR requirements.
- Report any potential or actual security breaches to the regional and/or global DPO.
- Contribute towards achievement of PIMS Objectives.
Qualifications and desired skills:
- Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream.
- Oncology and Rare disease case processing experience Experience working in Argus safety database for Post
- Marketing, Literature, Investigator Sponsored Research,
- and Clinical Trials Sound knowledge of Microsoft Office, specifically working in Excel.
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