The position is responsible for providing safety management, medical oversight and assessment of pharmacovigilance activities as assigned.
- Identifies, communicates and effectively manages potential safety issues
- Works closely with pharmacovigilance colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
- Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical safety information
- Provides investigator support regarding safety concerns, medical emergencies, etc
- Participates in medical safety surveillance/signal detection benefit/risk assessment, and development of trend analyses
- Participates in development of REMS and RMP as required
- Discusses and resolves medical issues with clinical sites, clients, and drug safety staff
- Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs)
- Consults with internal and external customers in the area of drug safety
- Supports business development through participation in core proposal team activities, feasibility assessments and review of proposals/contracts for medical services
- Maintains medical and pharmacovigilance expertise through appropriate CME
- Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
- English, Japanese is mandatory
- The incumbent should possess M.D., B.M.B.S., D.O. or equivalent degree from an accredited medical school
- Minimum one year of experience in the pharmaceutical, biotechnology or device industry working in pharmacovigilance/epidemiology
- Knowledge of global pharmacovigilance regulations and processes
- Computer proficient
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
Associate GSPV Medical Director