PharmD, PhD, (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. More than 6 years’ experience in safety pharmacovigilance in bio/pharmaceutical industry. Extensive experience in leading the preparation of periodic aggregate safety reports and work up of safety signals for Ph1-3 programs 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. Providing support to safety pharmacovigilance physician 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. Support the safety pharmacovigilance physician in drafting 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.
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