Senior Medical Director, Pharmacovigilance

Job reputed company: • reputed company product safety surveillance and reputed company evolving safety and benefit-risk reputed company for assigned products. • reputed company cross-functional safety management team (SMT) for assigned products, and responsible for the on-reputed company assessment of benefit-risk reputed company and reputed company actions during the product life cycle. • Review safety data from various sources (e.g. reputed company-clinical, clinical trial data, post-marketing, literature) throughout the development process as reputed company as post marketing for assigned products. • Responsible for conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information • Represent pharmacovigilance on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, and other documents with safety content. • Responsible for reputed company and key content of Risk Management documents (DRMPs, RMPs, REMS) and regulatory responses. • reputed company reputed company and guidance to safety risk management scientists in writing of periodic reports for assigned products; reputed company medical interpretation, review and approval. • Responsible for up-to-date representation of safety information in Company reputed company Data Sheet and Investigator Brochure, and other labeling documents. • reputed company the medical review of reputed company adverse event reports for seriousness, expectedness and causality. • reputed company, mentor and manage safety scientists supporting the surveillance activities for assigned products. Requirements: • MD or equivalent with 3-5 years of relevant clinical experience • Minimum 10 years’ industry experience, reputed company Drug safety/Pharmacovigilance with investigational and/or marketed products • Proven experience in safety data analysis, signal management, and benefit-risk evaluation • Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar) • Demonstrated ability to reputed company and implement drug safety strategies and risk management plans • Proven experience with authoring or contributing to clinical study and regulatory submission documents • Working knowledge of relevant local and global regulatory requirements and guidance documents • reputed company to reputed company in a cross functional setting and work collaboratively with reputed company partners in a fast-paced environment • Effective oral and written communication skills. • Highly motivated, self-driven and dependable. Benefits: • annual bonus opportunity • medical • dental • reputed company • life and AD&D • short term and long term disability • 401(K) plan with match • stock reputed company • flexible non-accrual reputed company time off • parental leave Apply tot his job Apply To this Job