Pharmacovigilance Scientist Post Vacant in Global Drug Development Division @ Novartis

As a science-based and patient-oriented healthcare company, we strive to be a global leader in growing areas of healthcare. Following a corporate transformation Novartis globally is focused on three divisions with global scale and innovation power – pharmaceuticals, eye care and generic medicines. This has strengthened the future growth prospects of the company.

Job ID : 196383BR

Position Title : Pharmacovigilance Scientist

Division : Global Drug Development

Business Unit : CMO & PATIENT SAFETY GDD

Country : India

Work Location : Hyderabad

Functional Area : Research & Development

Job Type : Full Time

Employment Type : Regular

Minimum requirements Education (minimum/desirable): Life sciences degree / Nursing background Languages: Good knowledge/fluency in English. Knowledge of other languages desirable.

Experience/Professional requirement: 3-5 years experience in Drug safety / Development or closely related areas of responsibility Experience of safety document writing

Job Description :

• Subject Matter Expert
• Contribute to DS&E projects
• Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents.
• Author/co-author, along with Global Medical Safety Physicians, regulatory periodic safety re- ports (Periodic Safety Update Reports, US Periodic Reports) for Novartis mature portfolio: collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures.
• Lead/co-lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing).
• Review global marketing programs and establish process for AEs collection with global marketing teams.
• Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of Pharmacovigilance commitments.
• Collaborate with Electronic Data Management team to reconcile Serious Adverse Events be- tween the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database.
• Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
• Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and database, authoring or contributing to Product Specific Guidelines for assigned products.
• Contribute to the preparation of Standard Operating Procedures and Argus processing conventions (MAP).
• Support the development and testing of safety systems/IT applications and in the preparation of relevant manuals.
• Support Health Authorities inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings.
• Train and mentor new DS&E associates.
• Number, timeliness and quality of deliverable according to established directives.
• Ability to learn quickly
• Consistent demonstration of company values & behavior

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