A Bio-Pharamceutical company specialising in Rare Diseases are looking for a Snr. Safety Scientist on a 6 Month Contract (with potential to go permanent).
The Safety Scientist is responsible for safety support of the company’s portfolio of products, oversight of company’s development partner CROs safety related activities and under supervision of the Therapy Area Heads (TAH) and Chief Medical Officer (CMO).
Hours: 25 -37.5 hours per week.-. Occasionally may be required to work outside these hours, including international travel, by prior agreement.
– Oversight of CRO delegated safety-related and pharmacovigilance activities.
– Leads monthly safety data review meetings and quarterly Product Safety Team meetings with CRO partners with support from TAH
– Assessment and clinical review of (S)AEs and AESIs events reported in clients clinical trials, drives data queries as needed, reviews narratives.
– Determination of seriousness, relatedness and causality of SAEs, oversight and review of SUSAR of case report narratives and AOSEs with oversights form TAH
– With TAH oversight, develops 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. Contributes to development and review of Medical Monitoring Plans.
– With oversight of TAH leads input and review of development safety update reports (DSURs) and Investigator Brochure updates, case narratives and any other safety documentation, thus contributing to high quality standard documents within the organization
– Leads development of clients response to 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 safety data and contributes to analysis planning.
– Supports/draft safety section writing for clinical trial protocols, clinical study reports, informed consent forms and statistical analysis plans
– Supports/drafts 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
– Provides support and safety input to data review and presentations for client Portfolio Safety Board,
– Adjudication Committees, Independent Data monitoring committee meetings
– Researches, reviews and interprets scientific and clinical literature
– Involved in review process of essential documents (e.g. IBs, protocols, eCRFs, medical monitoring plans, PILs, informed consents).
– Provides safety input to the Business Development team, including but not limited to review of available clinical data with respect to potential products for acquisition.
– Supports business development and TA Heads in response to safety-related questions on client products from potential investors or partners.
– Contributes to the development of clinical study reports.
– At times may be requested to perform additional activities, relevant to experience and needs, an example would be support of scientific publications or presentations.
MINIMUM EDUCATION REQUIREMENTS
– Relevant Science Degree
MINIMUM EXPERIENCE REQUIREMENTS
– Min. 5 years experience in safety roles including assessment of adverse events
– Experience in oversight of CRO’s in safety role desirable
If you’re interested, please submit your application online or contact email@example.com