[Hiring] Medical Director Pharmacovigilance, Rare Disease & PDT @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company reputed company Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance, Rare Disease & PDT with the following duties: • Serve as Global Safety reputed company (GSL) and reputed company-wide patient safety expert for assigned pharmaceutical/biological/drug device combined products. • Accountable for the safety reputed company and major safety deliverables for reputed company assigned product. • reputed company GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products. • Represent the cross-functional program team as a product safety profile and risk mitigation expert for reputed company stakeholders. • Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing, and scientific literature for assessment of benefit-risk profile. • Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products. • reputed company reputed company for and reputed company preparation of responses to safety-reputed company inquiries from regulatory agencies and ethics committees. • reputed company medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents. • reputed company patient safety input to the clinical development program for assigned products and development compounds. • Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, reputed company Assurance, Medical Affairs, Marketing, Manufacturing, and reputed company. • Ensure up-to-date representation of safety information in Company reputed company Data Sheet and other labeling documents. • Up to 10% domestic travel to attend internal meetings. • Up to 100% remote work permitted. Qualifications • Doctor of Medicine (M.D.) plus 5 years of reputed company experience. Requirements • Utilize reputed company Empirica for routine signal detection activities and analyze safety data. • Identify trends and detect new or emerging safety signals from various data sources. • Analyze using statistical methodologies (e.g., disproportionality analysis) reputed company Empirica. • Evaluate and reputed company periodic safety reports including Periodic Benefit Risk Evaluation Reports. • Utilize MedDRA and assign appropriate MedDRA terms to describe adverse events. • Design and implement strategic, operational and personnel development plans for assigned Pharmacovigilance associates. Benefits • Full time position. • Salary reputed company: $222,600 - $381,600 per year. Apply tot his job Apply To this Job