A BioPharmaceutical company specialising in rare diseases require an experienced Senior Safety Physician for a 6 Month Initial Contract.
The Physician is responsible for the medical and safety support of the clients’ portfolio of products, in collaboration with their development partner CROs. In addition, the Physician will provide medical input to support the company’s Corporate Development activities for existing assets and potential acquisitions.
– Oversight of CRO delegated safety-related activities such as medical monitoring and pharmaco-vigilence.
– Assessment and medical review of (S)AEs and AESIs events reported in clinical trials, drives data queries as needed
– Determination of seriousness, relatedness and causality of SAEs, oversight and review to SUSAR of case report narratives and AOSEs
– Leads safety surveillance strategy and signal detection for individual assets, and tracks and evaluates potential issues. including Investigator Sponsored Studies (ISS)
– Develops and updates Product Safety Plans, Safety Management Plans, and Safety Study Specific Plans
– Leads the client’s medical input and review of development safety update reports (DSURs) and Investigator Brochure updates, case narratives and any other safety medical documentation, thus contributing to high quality standard documents within the organization
– Leads response to medical and safety requests from regulatory agencies
– Updates Reference Safety Information, Risk Management Plans and safety information in the Investigator Brochure as needed
– Reviews and interprets emerging clinical trial data and contributes to analysis planning.
– Providing medical and safety sections to clinical trial protocols, clinical study reports, informed consent forms and statistical analysis plans
– Contributes medical and safety related aspects of new drug applications / regulatory filings, including Benefit-Risk assessments
– Supports the CRO Medical Monitors and Informs the appropriate TA Head of clinically significant new information that might impact on the clinical development, including safety profile of the medicine
– Leads Portfolio Safety Board meetings.
– Provides clinical input to data review and presentations for Portfolio Safety Board, Adjudication Committees, Independent Data monitoring committee meetings
– Researches, reviews and interprets scientific and clinical literature
Qualifications and Experience:
– Medically qualified with current GMC registration and a preferably a UK License to Practice
– 3 years experience in safety roles including assessment of adverse events
– Experience in medical monitoring and oversight of CROs is desirable.
Knowledge and Skills
– Good knowledge of pharmacovigilance practices and tools (e.g. databases, signal detection tools, MedDRA) preferable
– Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
– Experience with rare diseases would be a significant advantage.
If you are interested, then please submit your application and you can contact Elliot Payne on either email@example.com or call on 07775 696425.