REF 1709422
07.01.2025 | Dubai | full time
- General
- Location: Dubai
- Occupancy: full time
- Description
- The Pharmacovigilance (PV) Scientist, reporting to the Head of Drug Safety & Pharmacovigilance is responsible for providing operational and scientific contributions for the Drug Safety/ Pharmacovigilance and Risk Management activities related to PMV’s product portfolio.
Primary Responsibilities:
*Medical safety expert for products.
*Signal detection, signal investigation and assessment, literature review, proactive management of the benefit-risk profile for assigned products and any resultant activities such as revisions to core safety information.
*Risk management activities, including risk strategies for assets in all phases of development and life-cycle.
*Routine PV activities of assigned programs including medical review, analysis of similar events, and literature review.
*Coding reviews and reconciliation activities in collaboration with Data Management.
*Coordination and project management of aggregate safety reports (e.g. PSURs/PBRERs, PADERs).
*Contribution to safety sections of key documents (e.g. protocols, ICFs, IBs, RMPs, CDS, labels, INDs).
*Contribution to regulatory submission documents, response to queries and other regulatory enquiries.
*Performs aggregate analyses of specific events across studies, prepares and presents safety analyses at the Safety Committees, and writes Safety Assessment Reports.
*Interacts with contract vendors (case processing, call center, etc.) to resolve safety-related issues.
*Contributes to Post Authorization Safety Studies (PASS) and safety registries.
*Reviews Safety Data Exchange Agreements as applicable.
*Supports the safety department in organizing post-marketing activities in all applicable regions.
*Contributes to and reviews SOPs.
*Serves as a PV Safety contact to other Atara’s departments, EU QPPV, clinical sites, vendors and partners.
*Prepares for regulatory inspections and audits and develops corrective action plans when needed.
*Prepares training material for internal and external safety presentations (e.g. investigators meetings, SIVs).
*Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust).
- Requirements
- Life science degree or a qualified health professional with a degree as pharmacy technician, pharmacist or nurse.
- Provisions
- Salary: to be discussed
- Employment visa
- Publisher
- direct employer
- up to 50 employees