Drug Safety / Pharmacovigilance Associate

Description:

This is an excellent opportunity for graduates with some pharmacovigilance/vigilance experience to develop their career in a growing organisation where there is lots of opportunity to develop and expand their knowledge and experience. An ideal candidate will be looking to take responsibility to shape, develop and own a system and associated processes. It’s a fast-paced environment with scope to work on multiple projects and requires a flexible and resourceful individual.

Key Accountabilities:

• Processing ICSRs in ARISg database involving all products (in details: case triage including seriousness and listedness, data entry and QC, causality assessment, submission to NCAs, follow-up, tracking and filing of the reports)
• Weekly literature review
• Data reconciliation with partners and affiliates
• Follow company’s SOPs, knowledge of GVP modules, especially VI and ICH (E2B)
• May be involved in projects which include signal management, PSUR, and CER.

Essential Technical Skills:

• Life Sciences graduate or proven vigilance experience.
• 6- 12 months experience in PV/medical device vigilance, Pharmacy, compliance, clinical trials or similar is desired.
• Knowledge of GVP modules, especially VI and ICH (E2B)