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Drug Safety Physician – DSP-IDO-2024-4391

Website Achieva Group Limited

An excellent opportunity has arisen to join a leading pharmaceutical company as a Drug Safety Physician.

RESPONSIBILITIES AND TASKS
• Accountable for all aspects of safety related primarily to assigned marketed products including medical review and assessment of post-marketing AE reports, aggregate reporting, signal detection, risk management, and risk minimization activities.
• May act as responsible DSP assigned to projects in early development.
• Leads the cross-functional Safety Management Team (SMT) for assigned products; responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical throughout life cycle product management.
• Coordinates and ensures good quality presentation by the SMT at Drug Safety Committee (DSC)
• Contributes to the initial development and updates of the core safety information of the CCDS for
marketed drugs.
• Responsible for responses on safety inquiries from regulatory authorities and supports the management
of safety inquiries from health care professionals, as needed.
• Coordinates and facilitates involvement of external experts (e.g., Independent Liver Safety Data Review
Board, Cardiologist experts etc.).

REQUIRED QUALIFICATIONS AND EXPERIENCE
• Doctor of Medicine degree with at least 5-year experience in global drug safety in the pharmaceutical or biotechnology industry.
• Possessing medicinal product and disease knowledge based on didactic and/or clinical experience, with additional knowledge in safety surveillance and pharmacovigilance.
• Full understanding of post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of post-marketing regulatory safety reports/documents.
• Knowledge of global safety regulations, Good Clinical Practice (GCP), Good pharmaco Vigilance Practice (GVP), and Pharmacovigilance compliance requirements.
• Previous experience with key safety documents such as Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Risk Management Plan (RMP), Company Core Data Sheet (CCDS) etc.
• Previous experience with safety signal identification methodology and risk minimization measures.
• Excellent medical writing skills.
• Good presentation skills.
• Excellent interpersonal, communication and negotiation skills.
• Good organizational and planning capabilities and ability to meet timelines.
• Previous experience with Argus Safety database is preferable.

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