Medical Director/Senior Director
Core
Leading a team of scientists and physicians to manage aggregate safety reporting, signal detection, and regulatory compliance for multiple client programs.
Role type
Senior Director, Pharmacovigilance
Builds
Aggregate safety reports (PADERs, PSURs/PBRERs, DSURs, ASRs), signal detection outputs, and regulatory submissions for pharmaceutical clients.
Domain
Life Sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
Strategic medical oversight, team leadership, signal evaluation, benefit-risk analysis, regulatory compliance management, inspection readiness, process optimization, AI-enabled transformation, cross-functional stakeholder liaison.
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead medical review activities and oversee operational delivery for aggregate safety reports and signal management; Drive planning and finalization of regulatory reports to ensure timely delivery; Provide strategic oversight for key aggregate safety reports and signal governance outputs; Lead medical assessment of safety data trends and benefit-risk analyses; Support authoring and maintenance of Risk Management Plans and Safety Management Plans; Act as liaison across cross-functional stakeholders to ensure compliant preparation of deliverables; Provide oversight to ensure safety database outputs align with reporting timelines and inspection standards; Lead and support health authority inspections and regulatory response preparation; Contribute to continuous improvement initiatives and AI-enabled transformation programs; Manage process improvements and automations in aggregate report services.
Seniority
Senior Director, strategic & operational leadership
