Medical Director/Senior Director

THE POSITION:

The 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

• Lead Medical Review activities and oversee pharmacovigilance operational delivery for aggregate safety reports, signal management activities, and regulatory compliance commitments across multiple client programs.
• Drive 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.
• Provide 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.
• Lead 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.
• Support 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.
• Act 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.
• Provide 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.
• Lead and support health authority inspections, sponsor audits, CAPA management activities, and regulatory response preparation related to aggregate reporting, medical review, and signal management processes.
• Contribute to continuous improvement initiatives, AI-enabled pharmacovigilance transformation programs, and process optimization efforts supporting scalable, high-quality aggregate reporting and signal detection operations.
• Participates 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.
• Manage process improvements and automations in aggregate report and signal services.
• Effective Client Management skills.
• Support RFP, Bid presentation and market research activities.
• Manage Revenue and Margin Goals for Aggregate and Signal Management projects.
• Manage other safety writing deliverables as needed.
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
• All other duties as assigned.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

• Education /MBBS/MD degree is preferred
• Experience and/or Training 15 years of relevant experience, which includes at least 8 years in signal and aggregate report writing domain
• Knowledge of pharmacovigilance regulations, safety data analysis, benefit-risk assessment, and post-marketing requirements.
• Strong 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). Proficiency with standard office software (Microsoft Office (i.e., Word, Excel, PowerPoint)) and formatting documents
• Broad knowledge of domestic and international drug safety regulations, industry practices and standards
• Excellent working knowledge of FDA, EU and international adverse event reporting regulations per ICH guidelines
• Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
• Understanding medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus