PURPOSE OF THE FUNCTIONThe Safety Risk Management Lead provides safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). S/he will perform ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.ROLES AND RESPONSIBILITIESLead safety signal management activities including data preparations and presentations. Assist GPS GSLs in their assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders internally.Prepare data for and actively participate in safety governance and risk management processes including safety management teams (SMT) and benefit-risk committees (BRC).Effectively lead, oversee and participate in the planning, preparation and review of periodic reports (DSUR, PSUR, PADER).Participate in the presentation and analysis of safety data from on-going and completed clinical trials.Review and provide safety input, as needed, for key study-related documents, e.G., Investigator’s Brochure (IB), Informed Consent Form (ICF), Independent Data Monitoring Committee (IDMC) Charter.Participate in protocol development and review, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans, as needed.Participate in departmental development activities including SOP and Work Instructions development.Perform other activities as needed to assist with departmental activities.SKILLS AND COMPETENCIESKnowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settingsKnowledge of relevant global pharmacovigilance regulations and guidelinesAbility to prepare and/or review high quality safety documents, including periodic aggregate safety reports, signal evaluation report, or risk management plans.Ability to communicate complex issues effectivelyAbility to influence and collaborate with multidisciplinary teamsAbility to prioritize and plan proactivelyExcellent analytical and problem-solving skills, with sound autonomy and applied judgmentExperience with MedDRA, WHO Drug DictionaryUnderstanding of the principles of databases, querying data sources as well as developing and applying search strategiesRelevant computer skills including proficiency with Microsoft OfficeFluency in written and spoken EnglishEDUCATION, EXPERIENCE AND QUALIFICATIONSBachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life sciences or technical fields (Ph. D. or M.D a plus)Minimum of 7-10 years of relevant pharmaceutical/biotech industry or healthcare experiencePharmacovigilance/safety risk management experience is strongly preferred For applicants in the United States: The annual base salary hiring range for this position is $164,000.00 - $246,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.