MSI Pharma are working with a well known Biotech company to sourse an experienced Safety Physician for this permanent role.
Responsibilities and Requirements for this role include:
· Doctor of Medicine degree with at least 7-year experience in clinical and post-marketing safety and/or clinical development in the pharmaceutical or biotechnology industry
· Broad scientific background and excellent clinical development knowledge, experience and ability to interpret clinical study safety information.
· Possessing extensive medicinal product and disease knowledge based on didactic and clinical experience, with considerable additional expertise in safety surveillance and pharmacovigilance
· Full understanding of the Clinical trials and post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of investigational and post-marketing regulatory safety reports/documents.
· Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements.
· Previous experience with regulatory filing and contribution to key safety documents such as Integrated Summary Safety document, Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Risk Management Plan (RMP), Company Core Data Sheet (CCDS) etc
· Good experience and knowledge 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.
Responsibilities and Tasks
· Accountable for all aspects of safety related to the assigned projects/products including medical assessment, aggregate reporting, signal detection, risk management, and risk minimization activities throughout the products life cycle.
· Leads the cross-functional Safety Management Team (SMT) for assigned projects/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 Idorsia Drug Safety Committee (DSC), with an accurate review of the safety profile of the product including presentation of implemented safety measures and SMT recommendations
· Provide drug safety expertise in all phases of drug development. Participate and contribute 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 contribute to other key regulatory key safety documents such as Integrated Summary Safety (ISS), RMP/Risk Evaluation and Mitigation Strategy (REMS).
· Responsible for the preparation and maintenance of the Development Pharmacovigilance Plan (DPvP) for Investigational Medicinal Products (IMPs).
· Review, contribute and provide medical and safety expertise for study synopsis, protocol, Core Informed Consent (CIC), Briefing Book (BB), Clinical Development Plan (CDP), Clinical Study Report (CSR), Investigational Medicinal Product Dossier (IMPD), Statistical Analysis Plan (SAP) and Pediatric Investigation Plan (PIP) as required.
· Represents Idorsia in interactions with Health Authorities and Independent Data Safety Monitoring Board activities for safety related topics
· 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 or health care professionals
· 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.