Drug Safety Physician

Job Title: Drug Safety Physician

Work Location: Allschwil

Country: Switzerland Schedule: Fulltime (100%)

Desired start date: ASAP

Duration: 12 months

Contractor Rate: CHF 103.39 – CHF 120.34 depending on seniority

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 SMTs  Drug Safety Committee (DSC) with an accurate review of the safety profile of the product including presentation of implemented safety measures and SMT recommendations.
• Participates and contributes to Clinical Project Team (CPT) and Life Cycle Team (LCT) meetings.
• Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information.
• Responsible for the preparation of aggregated periodic safety reports (DSUR, PSUR/PBRER), Reference Safety Information (RSI) section of the Investigator Brochure (IB) and contributes to other key regulatory key safety documents such as RMP/Risk Evaluation and Mitigation Strategy (REMS).
• Responsible for the triage and medical review of adverse event (AE) reports received from all sources for assigned projects/products to ensure proper coding, seriousness, expectedness and causality assessment and request medically relevant follow up information for proper documentation and evaluation of the cases.
• 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.).
• Provides support as needed for licensing agreements (e.g., co-development safety data exchange agreements).
• Supports the management of regulatory Heath Authority inspections as deemed necessary.
• Works closely with Quality Management in the review of technical product complaints associated with an AE for assigned projects/ products and provide scientific input and expertise to the recall committee as needed.

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.

Apply:

It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 104914 in all correspondence.