Pharmacovigilance

TCS combines tech expertise and business intelligence to catalyze change and deliver results. Our mission is to help customers achieve their business objectives by providing innovative, best-in-class consulting, IT solutions and services and to make it a joy for all stakeholders to work with us. Clinical Data, Regulatory, Clinical Operations, Pharmacovigilance; Should be open to work In shifts

Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety pharmacovigilance/clinical development.

Maintaining up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting. Collaborating with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.

Ability to develop key partnerships internally and externally, influence and negotiate with key personnel, and plan strategically with a systems thinking approach.

End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules.

The Manager Drug Safety Content Analysis will manage and supervise project’s PV Operations/training staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of training, quality of deliverables, compliance with the timelines and relevant trainings.

Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article. Demonstrates understanding of client’s drugs labels and uses that knowledge effectively when performing the safety assessments.

Responsible for processing of Individual Case Safety Reports ICSRs from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable 

Supervise and lead the team of analytical development, Analytical method validation, technology transfer, forced degradation study, preformulation study, dissolution studies, Extractable and Leachable and technical query handling. Candidates must have exposure of Pharma regulatory approved organisations USFDA, MHRA, Eu and other Major regulatory bodies