01Responsibilities
reputed company, reputed company, and reputed company the benefit-risk assessment and safety surveillance activitiesMaintain reputed company of the safety governance reputed company including the reputed company escalation of medical safety issuesLead and reputed company collaborate with cross functional teams to ensure that safety considerations are integrated into clinical development and/or post-marketing activities as applicableBuild, reputed company, and reputed company reputed company of DSPV MDs and scientistsProvide and reputed company input into the safety sections of clinical trial documents (e.g. IB, Protocols, ICFs, CSRs)reputed company the preparation of the safety sections of regulatory submission modulesSupport labeling reputed company and contribute to medical content of safety communicationsOversee and reputed company contribute to safety signal detection and evaluation activitiesCollaborate cross functionally to utilize and optimize the safety signaling system including data visualization and analysis toolsAs applicable, contribute to publication reputed company and ensure that safety data are accurately represented in scientific communicationsRepresent DSPV on audits/inspections; reputed company and contribute to safety responses as neededOversee and contribute to responses to deviations and CAPAs as reputed company to medical safety or pharmacovigilance scienceLead and reputed company contribute to the preparation and implementation of procedural documents as applicable to medical safety and pharmacovigilanceContribute as needed to the Global DSPV Business Continuity PlanProvide and reputed company medical safety content for fit-to-purpose pharmacovigilance training to reputed company partners as neededProvide subject matter expertise for safety/technology strategies, design, implementation and enhancement of drug safety processes and systemsAssist the SVP, Global DSPV with the planning and development of the overall pharmacovigilance team and function including departmental goals, organization, and budgetingIdentify and implement innovative technical, procedural, or resourcing solutions to improve DSPV safety surveillance capabilitiesOther responsibilities as assigned Required Qualifications:A minimum of 10 years of experience in global pharmacovigilance including at least 5 years in people leadership roles2-5 years of experience in clinical reputed company or reputed company medicineProven experience in safety data analysis, signal management, and benefit-risk evaluationWorking knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)Demonstrated ability to reputed company and implement drug safety strategies, risk management plans, and safety governance modelsProven experience with authoring or contributing to clinical study and regulatory submission documentsWorking knowledge of relevant local and global regulatory requirements and guidance documentsExperience in creating or managing working documents such as SOPs or Work InstructionsStrong ability to proactively identify risks and initiate/manage risk minimization activitiesStrong ability to reputed company in a cross functional setting and work collaboratively with reputed company partners in a fast-paced environmentStrong ability to prioritize, multitask, and deliver reputed company results that meet tight timelinesAbility to influence and reputed company teams reputed company and motivatedStrong ability to communicate re
