Job Purpose:
Provide Medical expertise and guidance to support Case Processing and Aggregate Reporting, and participate in proactive pharmacovigilance activities

Major Accountabilities:
All Medical Surveillance Expert (MSE) I activities, including:
*Research potential safety concerns for presentation to Product Stewardship Committee
*Review line listings for Non-Serious cases
*Review and provide additional input to periodic reports ( USPR, PSUR, etc)
*Review and approve QA Reports (APR / LOE reports)
*Generate responses for Health Authorities
*Provide safety and pharmacovigilance perspective in Global Brand Meetings
*Evaluate individual case safety report and provide medical assessment for serious cases
*Responsible for signal detection, analysis, and management
*Prepare responses to medical inquiries
*Provide expertise for developing procedures to capture, manage and report clinical trial safety data
*PDP and BFI prep for new products
*Provide ongoing guidance to Case Processing regarding data capture and coding
*Perform due diligence for new products
*Prepare responses for renewals, ad hoc requests, and label updates

MSE II activities:
*Responsible for the overall safety for his/her Category products and implementation of the Benefit/Risk Man-agement strategy
*Responsible for the evaluation of safety signals
*Lead assigned activities related to signal detection, analysis, and management
*Contribute to NDA applications
*Prepare Risk Management plans
*Represent Drug Safety and Pharmacovigilance in meetings with the Health AuthoritiesEducation:
MD required

Experience:
Minimum 5 years experience in health care or pharmaceutical industry with a minimum of 2 years in Drug Safety*, Minimum 1 year OTC ex-perience, Signal detection and risk management plan experience re-quired. Management experience preferred

*Experience requirement can be reduced with advanced education or equivalent relevant clinical experience