This role will lead the clinical safety pharmacovigilance (PV) activities within expected scope and timelines. The incumbent will play a major role in ensuring the safety pharmacovigilance deliverables and processes are followed and support the establishment and growth of PV functions to assure global capabilities and execution.

Key Roles & Responsibilities

• Lead clinical safety pharmacovigilance in conducting safety surveillance of assigned products.
• Prepare and manage the aggregate reports draft, finalization and submission timelines by working closely with CROs and relevant department contributors.
• Draft the safety sections of aggregate reports, IB, protocols, health authority responses, data management or safety management committee presentations and other similar activities.
• Accountable for the delivery of assigned tasks according to quality, time, budgets, and resources.
• Liaise with case processing team internally and CROs to ensure timely delivery of all case processing and health authorities’ commitments for PV safety.
• Partner with pharmacovigilance operations, clinical development and operations, regulatory and other functional areas for the successful implementation and execution of all PV commitments.
• Act as a safety pharmacovigilance resource in interactions with internal and external stakeholders.

Role Requirements

• MD (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
• Experience in pharmaceutical or biotech industry working with Phase I – III clinical trials, experience in Oncology safety surveillance is highly desired.
• Experience working with safety databases such as Argus, ArisG, Oracle or equivalent.
• Clinical experience as practicing physician post residency training for 2-3 years is desirable.
• More than 6-8 years’ experience in safety pharmacovigilance in bio/pharmaceutical industry.
• Extensive experience in leading the preparation of periodic aggregate safety reports; deep understanding of signal detection and management in pre and post market setting is essential.
• Independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style.
• Ability to manage multiple projects in a fast-paced environment with global teams in different time zones.
• Excellent organizational communication and coordination skills.
• Good interpersonal and ownership.