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Job Field: Security
Location: United States, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00389240Job350of371Safety Scientist (Virology)South San Francisco, CaliforniaJob factsJob functionDrug SafetyLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionThe Safety Scientist is responsible for carrying outpharmacovigilance activities on a product or group of products, includingsingle case processing, aggregate reporting, signal detection and evaluation ofPV database. The Safety Scientist supports the Safety Science Leader andis responsible for a particular aspect(s) or segments of the overallprogram. He/She contributes to the benefit risk evaluation and tosafety risk management.Responsibilities include:Carry outpharmacovigilance and risk management activities for specific product orproducts:* Contribute toPharmacovigilance and Risk Management planning for designated products bypreparation of safety surveillance strategy and highlighting and trackingpotential issues* Prepare and reviewperiodic safety reports (PSUR, EU Annual Safety Reports) in accordance withregulatory requirements and PDMS standard operating procedures* Coordinate safetyactivities between PDS and internal and external partnersCarry out signaldetection activities and evaluation:* Conduct/supportsignal detection and evaluation according to SOPs and guidelines* Carry out medicalreview of spontaneous case reports and Serious Adverse Event reports from clinicaltrials, according to SOPs and guidelines* Prepare Drug Safetyreports, as necessary, for potential signals* Respond to queriesrelevant to the safety of Roche products from the affiliates and other internalfunctionsContribute drug safetyinput to activities to define and implement the Clinical Developmentstrategy for a product or group of products:* Providereview of clinical protocols and study reports to ensure alignment with CDP andsafety adequately addressed, and contributes to the safety section of theInvestigators Brochure (IB)* Contribute toregulatory authority submissions (NDAs, MAAs, Variations) by reviewing safetydata and preparing relevant sections of the submissionWho You AreMinimum:MD is preferredPhD, PharmD, Pharm, MS or equivalent qualification and good medical competence in the relevant therapeutic area may be consideredRequired Skills/Experience:* Prior experience in safety is desirable (at least 2 years)* MD candidates with solid pharmaceutical experience in clinical development or medical affairs (at least 3 years)* Industry experience in drug safety or clinical development* 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 * Team player with ability to function in a multi-disciplinary environment*LI-PM1

KEY REQUIREMENTS:

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