Safety Science Associate Director

Safety Science Associate DirectorSouth San FranciscoCalifornia,

United States of AmericaJob ID: 202008-121861Download PDFApply For This JobReturn to Search ResultsThe PositionJob ResponsibilitiesUnder the matrix leadership of the SSL and in collaboration with PCS colleagues● Develop and maintain an understanding of the safety profile of their assignedproduct(s) or therapy areas. Develop and maintain an expert understanding ofthe safety profile of the assigned product(s) as well as understanding of therelevant strategic context (e.g., disease under study, safety profile of competitors,mechanism of action)● Responsible for individual and aggregate case reporting activities including ICSRcase management (medical review) and aggregate reporting (i.e. DSUR,PBRER)● Responsible for signal detection and management activities including, but notlimited to STAR maintenance, ISMP maintenance. Contribute to the strategy andreview of safety assessments and drug safety reports for signals or issues (inc,product quality) or in response to Regulatory Authority requests● Contribute to the development of the product safety strategy and provide drugsafety input into the Clinical Development strategy● Contributing to risk management activities including preparation andmaintenance of CCDS, labeling document maintenance (including the IB), riskcommunications, RMP, REMS● Contributing to study management from a safety perspective through SMT/PETactivities and document review and maintenance across the developmentcontinuum (early phase to post marketing studies), including PASS● Contribute to regulatory authority submissions (Investigational New Drug/INDapplications, New Drug Applications/NDAs, Marketing AuthorizationApplications/MAAs, Variations, Renewals, etc.) by reviewing safety data andpreparing relevant sections of the filing and submission packages in consultationwith SPL● Responsible for the preparation and maintenance of safety sections of theCompany Core Data Sheet and/or Reference Safety Information in the IB● Participate in and provide input for Drug Monitoring Committees (iDMC) orinternal monitoring committee (IMC) meetings, as applicable● In partnership with the SSL, support presentation of important safety issues tothe Drug Safety Committee (DSC), Development Review Committee (DRC) andother internal and external review and governance committees as needed.● Author or contribute to scientific publications (abstracts, posters, papers) forscientific meetings/journals● Acts independently to manage safety responsibilities on study teams and inactivities supporting safety science● Take on the responsibility for specialised roles with PCS. These may include, butare not limited to; functional business process owner, subject matter expert.Behaviours and responsibilities● Demonstrates independence and high competence in the conduct of all safetyscience responsibilities● Actively emulate and role model the Roche values, culture (mindset andbehavior), Roche core competencies and PD/PDS strategy and drive for similarVersion 1 1st October 2019performance across relevant team● Demonstrates behaviors consistent with Roche values and engendersconfidence from senior management● Develop and maintain knowledge of the pharmaceutical industry and drugdevelopment, including a comprehensive knowledge of pharmacovigilanceactivities and requirements● Ensure all actions are conducted in alignment with Roche quality managementsystems● Understands how safety activities contribute to company development andcommercialisation goals and takes measures to maximize safety value to theorganization● Establish and maintain collaborative working relationships with all keystakeholders, and internal and external customers and ensure the same acrossrelevant teams● Consistently comply with all governing laws, regulations, Roche standardoperating procedures (SOPs) and other guidelines● Responsible for coordination and collaboration with vendors servicing SafetyScience● Acts independently and with minimal supervision to manage safetyresponsibilities on study teams and in activities supporting safety science● Trains and mentors more junior PSS scientists● Proactively takes on responsibility for more complex deliverables● Takes on team leadership responsibility in order to manage and completemedium and high priority projects● Seen by peers and cross-functional colleagues as expert in some safety scienceactivities● Under certain conditions, may take on the role of “Safety Strategy Lead (SSL)”for one or more assigned molecules. The SSL is the lead safety accountable forthe molecule safety strategy.● Willing to challenge embedded behaviors/mindsets, in order to bring new andagile approaches to ways of working, and/or to improve quality and efficiency .● Holds themselves and peers accountable for their behaviours and actionsEducation, Skills and ExperienceMinimum Qualifications: Qualified healthcare professional or Life Sciences graduate.Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Lifesciences discipline; PharmD or other post-graduate health professional qualifications)would be advantageous.The ideal candidate has 4 or more years of drug development experience in thepharmaceutical or related industry including at least 2 years in drug safety or a closelyrelated field.● Understanding of GxP and regulated processes and end to end clinical triallifecycle● Strong orientation towards process improvement and cross-functional teamwork● Effectively work with remote partners on a global team● Excellent communication skills, both written and verbal● Apply complex data analysis / statistical methods to evaluate, interpret andpresent scientific data with clarity● Strong presentation skills, effective at summarizing and presenting the keyconsiderations and decision points● Ability to effectively train others on departmental practices and processes● Application of project management methodologyWho We AreA member of the Roche Group, Genentech has been at the forefront of the biotechnology industry

for more than 40 years, using human genetic information to develop novel medicines for serious and

life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious

illnesses. Please take this opportunity to learn about Genentech where we believe that our employees

are our most important asset & are dedicated to remaining a great place to work.The next step is yours. To apply today, click on the "Apply online" button.Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.Return to Search ResultsJoin our Talent Community.

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