01Overview
Summary
Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products life cycle.
Provides safety support to the clinical development teams.
About The Role
Major Accountabilities
Lead and oversee day-to-day MSA & EE operations, ensuring timely and high-quality delivery of all assigned safety and operational activities.Drive compliance, inspection readiness, and adherence to global pharmacovigilance regulations, quality standards, and internal procedures.Act as deputy for Group Leads when required, including governance participation, MRQC arbitration, decision-making, and operational oversight.Provide leadership and accountability for strategic initiatives, ensuring deliverables, timelines, quality outcomes, risk mitigation, and business continuity planning.Lead and support safety deliverables for PVA 3 and PVA 4 compounds, ensuring effective execution and stakeholder alignment.Identify, drive, and implement continuous process improvements to enhance efficiency, quality, compliance, and operational excellence across safety activities.Proactively monitor performance metrics, identify risks and issues, conduct effectiveness checks, and implement corrective actions to ensure sustained operational effectiveness.Support pharmacovigilance audits and inspections by contributing to inspection readiness activities, serving as a Subject Matter Expert (SME), and addressing audit findings.Collaborate with external service providers (ESPs) and cross-functional stakeholders through governance forums, training, communication, and performance management activities.Partner with PS&PV Quality and Clinical Quality teams to implement Quality Plans and ensure timely closure and tracking of all CAPAs arising from audits, inspections, and quality reviews.
Minimum Requirements
Advanced degree in Healthcare/Life Sciences preferred (MD, MBBS, MSc, PharmD, PhD) with fluency in written and spoken English.Minimum 10 years of experience in Drug Safety, Pharmacovigilance (PV) Operations, and/or Project Management.Strong expertise in drug safety processes, including procedural documentation, workflow design, and operational excellence.Proven ability to lead and collaborate with large cross-functional teams in complex, global initiatives.Results-oriented professional with a proactive, accountable, and quality-focused approach, capable of working effectively under pressure.Excellent communication, stakeholder management, planning, organizational, and computer skills, with the ability to manage multiple priorities in a dynamic environment.Demonstrated leadership capabilities, including mentoring, negotiation, conflict resolution, decision-making, problem-solving, and presentation skills.
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