AIG - Chief Operating Officer - Pharmacovigilance/Drug Safety

- 10+ years of leadership experience in Drug Safety/Pharmacovigilance operations

- Leading a team of 50-200 people consisting of drug safety physicians and experts

- Hands-on experience of Business Development in Europe and US

- Well-networked with International Community of Pharma Experts

- Client engagement/Collaboration and overall stakeholder management

Core competency in set up and management of end to end Pharmacovigilance Unit of International standards ensuring delivery of:

- Aggregate report writing (PADER, PSUR, and Annual Safety Reports) and medical assessment

- Medical Monitoring

- Signal detection, analysis and evaluation

- Product Risk Management (REMS)

- PV systems validation

- Provide drug safety leadership and ensure thorough understanding of adverse event management, workflow elements and compliance with local regulatory guidelines and Global Product Safety (GPS) policies, procedures and processes.

- Maintain proficiency in current knowledge of all applicable regulatory guidelines and regulations relating to safety reporting

- Interact with clients and internal staff to provide advice and guidance on safety review issues; provide training and consultation to clients

- Assist Business Development for client development presentations that involve safety reporting as a potential service; provide adequate input into client proposals

- Identify training needs in Pharmacovigilance and work with Training Group to implement appropriate training

- Advise management on adequate budget and resource planning

- Well versed with operational multitude of safety databases i.e. ARGUS, ARISg, AERS, PVNet