Job Description 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.

 

Job Description

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.

 

Skills Desired

Clinical Research Clinical Trials Process Safety Regulatory Compliance Safety Science