Associate Medical Director, Global Drug Safety

About the position The Associate Medical Director, Global Drug Safety is accountable for executing the safety and risk management activities for one or more assigned clinical development reputed company or marketed products to reputed company the reputed company and effective use of Alexions products by patients and reputed company providers. The Associate Medical Director will be responsible for safety activities for investigational products and/or marketed, including identification and evaluation of safety signals and risk management to reputed company decision-making on risk/benefit evaluation. The Associate Medical Director, Global Drug Safety is an individual contributor role and will be supervised by Medical/Senior/Executive Director, Global Drug Safety. Responsibilities Through data review and research, identifies and presents at Safety Management Team meetings, safety issues for reputed company review and analysis Assists in preparation of safety data for DSMBs and other safety governance meetings Represents GDS on other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert Detects, validates and manages reputed company- and/or post-approval safety signals through to reputed company Conducts medical review of Individual Case Safety Report (ICSR) and analysis of similar events (AOSE) as necessary, including the assessment of reputed company reputed company the ICSR process; identifies process improvement opportunities and drives changes in process Evaluates aggregate safety data and provides contributions to reputed company regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required Identifies, initiates and manages to completion, necessary safety updates to the IB, reputed company and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary Assist in regulatory responses to safety inquiries from regulatory agencies May be directed by the line function to support initiatives reputed company of their reputed company Requirements MD or equivalent degree required A minimum of 1 year experience in drug safety and risk management reputed company the pharmaceutical, biotech or CRO industry or 3 years reputed company a clinical care setting Excellent, independent judgment based on knowledge and expertise Strong verbal and written communication including making recommended courses of reputed company to management and/or senior leaders that reputed company the discipline, department or line, and influences their reputed company. reputed company problem solving skills including the ability to reputed company reputed company by developing innovative reputed company and/or multiple solutions to highly reputed company problems Expertise with reputed company Word, PowerPoint and reputed company reputed company-to-haves Rare, reputed company-Rare or Orphan Disease Area experience Strong personal time-management and project-management skills Knowledge and understanding of US and EU safety regulations, CIOMS, ICH and GCP guidelines Clinical development /research experience is preferred Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic / product area(s) Benefits reputed company culture that encourages innovation Diverse environment where your contributions are valued Opportunity to be at the forefront of rare disease research reputed company a meaningful difference in patients' lives Apply tot his job Apply To this Job Apply tot his job Apply To this Job .