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Drug Safety Associate Full-time Job

Sep 11th, 2024 at 01:03   Medical & Healthcare   Navi Mumbai   45 views Reference: 7461
Job Details

As a Drug Safety Associate, you will be responsible for the collection, processing, and reporting of adverse drug reactions (ADRs) and other safety-related data. This position involves reviewing and validating safety reports to ensure they are complete and accurate before submission to regulatory authorities. The associate will manage the end-to-end process of safety data handling, including data entry, case assessment, and follow-up with healthcare professionals or patients. The role requires coordination with clinical teams, regulatory affairs, and other departments to ensure that safety information is managed effectively and in compliance with regulatory guidelines. The associate will contribute to the preparation of safety reports, including individual case safety reports (ICSRs) and periodic safety update reports (PSURs). Key responsibilities also include monitoring safety databases for new and emerging safety signals, and assisting with risk assessment and management activities. The position demands a keen eye for detail, excellent organizational skills, and the ability to handle multiple tasks simultaneously. Experience with pharmacovigilance systems and safety reporting tools is essential. Strong communication skills are required for effective interaction with internal teams and external stakeholders. A degree in life sciences or a related field is necessary, with prior experience in drug safety or pharmacovigilance preferred. The role may also involve participating in training and development activities to stay updated on regulatory changes and best practices in pharmacovigilance.

Company Description
Indegene