Pharmacovigilance

Monitoring CAPA till completion, Management of lateness documentation form, identify the Deviation Owner, Follow-up in case of no response, Identify potential critical and major systemic deviation and escalate as required. Identify Trends during ongoing investigations and as part of retrospective reviews.

Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical, scientific content through utilizing the correct channel mix, which will differentiate AstraZeneca products from those of other companies.

In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Your expected interactions are within your own team and direct supervisor.

BPharm, BSc, MPharm, MSc, MBBS, BAMS; Experience in PV/ Clinical Research drug safety preferred. Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data.

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.