Medical Director/Senior Director

THE POSITION:\nThe position supports Pharmacovigilance department as a key member primarily contributing to leading a team that comprises of aggregate report scientists and physician(s) involved in aggregate report writing and signal detection.\n\nESSENTIAL DUTIES AND RESPONSIBILITIES:\nOur employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:\nLead Medical Review activities and oversee pharmacovigilance operational delivery for aggregate safety reports, signal management activities, and regulatory compliance commitments across multiple client programs.\nDrive the planning, tracking, and finalization of aggregate reports, signal detection outputs, cumulative analyses, and ad hoc line listings to ensure timely delivery in accordance with global regulatory requirements and client expectations.\nProvide strategic medical and operational oversight for the preparation and review of key aggregate safety reports including PADERs, PSURs/PBRERs, DSURs, ASRs, IND Annual Reports, Risk Evaluation reports, and client-specific signal detection and safety governance outputs.\nLead medical assessment and review of safety data trends, signal evaluation activities, and benefit-risk analyses to support ongoing product safety surveillance and regulatory decision-making.\nSupport authoring, review, and maintenance of Risk Management Plans (RMPs), PSMFs, Safety Management Plans (SMPs), Pharmacovigilance Agreements (PVAs), and Safety Data Exchange Agreements (SDEAs) in collaboration with Safety Science, PV Operations, Medical Review teams, and Project Management.\nAct as a key liaison across cross-functional stakeholders including medical reviewers, safety scientists, PV operations, biostatistics, regulatory affairs, and clients to ensure accurate and compliant preparation through submission of aggregate and signal management deliverables.\nProvide operational and strategic oversight to ensure safety database outputs, medical review inputs, and signal management activities align with reporting timelines, regulatory expectations, and inspection readiness standards.\nLead and support health authority inspections, sponsor audits, CAPA management activities, and regulatory response preparation related to aggregate reporting, medical review, and signal management processes.\nContribute to continuous improvement initiatives, AI-enabled pharmacovigilance transformation programs, and process optimization efforts supporting scalable, high-quality aggregate reporting and signal detection operations.\nParticipates in cross-functional teams to create/refine policies to develop and promote best practices, processes, identify new tools, and develop new policies to promote consistent aggregate reports excellence, monitor performance trends and drive continue process improvements related to aggregate reports.\nManage process improvements and automations in aggregate report and signal services.\nEffective Client Management skills.\nSupport RFP, Bid presentation and market research activities.\nManage Revenue and Margin Goals for Aggregate and Signal Management projects.\nManage other safety writing deliverables as needed.\nDemonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.\nAll other duties as assigned.\nMINIMUM KNOWLEDGE, SKILLS AND ABILITIES:\nThe requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.\n\nEducation /MBBS/MD degree is preferred\nExperience and/or Training 15 years of relevant experience, which includes at least 8 years in signal and aggregate report writing domain\nKnowledge of pharmacovigilance regulations, safety data analysis, benefit-risk assessment, and post-marketing requirements.\nStrong attention to detail with a proactive persistence approach to following tasks through to completion. Working with clients/sponsors, clinical research organization(s) (CRO), vendors, and license partner(s).