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
