Saftey Scientists are needed for 12-month contract positions at major biotech company in Northern California.The Safety Scientist is responsible for carrying out pharmacovigilance activities on a product or group of products. This may include single case medical review, aggregate reporting, signal detection and evaluation, and other safety related activities e.g. associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management. The Safety Scientist supports the Safety Science Leader and is responsible for a particular aspect(s) or segments of the overall program or a group of products. Primary Responsibilities and Accountabilities Carry out pharmacovigilance and risk management activities for specific product or products:• Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues• Support the preparation and maintenance of Risk Management plans • Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures• Support the preparation and maintenance of safety sections of the Company Core Data Sheet• Lead/support PDS post-marketing safety study activities• Coordinate safety activities between PDS and internal and external partnersCarry out signal detection activities and evaluation:• Conduct/support signal detection and evaluation according to SOPs and guidelines• Carry out medical review of individual case safety reports (ICSRs), if assigned for the product according to SOPs and guidelines• Prepare safety assessments, drug safety reports, as necessary, for potential signals or issues (product quality)• Respond to safety requests for the assigned product from regulatory agencies or affiliates/ other internal functions Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products:• Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP • Contribute to regulatory agency submissions (IND applications, NDAs, MAA’s, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages • Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable• The Safety Scientist should develop a clear understanding of the safety issues and a thorough knowledge of the from the drug mode of action, to enable support the SSL• The timely medically and scientifically sound development of the clinical safety portions of a product development plan (PDP) and develop an understanding of the safety profile of the assigned productWhenever assigned by the SSL, the Safety Scientist is responsible for the development and whenever appropriates the execution of RMP or REMS risk mitigation tactics.Minimum REQUIREMENTS: Education and Experience:• Minimum: MD, PhD or PharmD, RN or other healthcare degree required• Strong knowledge of international drug regulation including GCP, GVP and GMP• Prior industry experience in drug safety, clinical development or medical affairs is desirable • MD candidates - clinical practice experience (at least 3 years preferred, may include residency) • Good knowledge of pharmacovigilance practices• Good knowledge of US and EU pharmacovigilance regulatory requirements• Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions• Ability to evaluate, interpret and synthesize scientific data (analytical thinking)• Team player with ability to function in a multi-disciplinary environment• Self –motivated, able to prioritize and plan effectively• Attention to detail• Fluent in English (verbal and written)• Good negotiating and influencing skills• Good computing/IT skills Travel Requirements: Able to undertake international travel as necessary
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