Requirement of Drug Safety Analyst at EMD Serono, Division of Merck & Co. | US - MA - Rockland
EMD Serono, Inc. is proud to belong to the oldest pharmaceutical and chemical company in the world. With a history spanning more than 300 years, our parent company, Merck KGaA, still operates successfully in both sectors. We are known in the United States as EMD, a name that stands for Emmanuel Merck, Darmstadt, heralding back to our roots in Germany.
Post: Drug Safety Analyst
PURPOSE OF THE ROLE
The purpose of this role is to provide for the timely initiation, tracking, data entry, and follow up of adverse event reports received for company products according to Federal Regulations and global and local quality documents.
All US Product Surveillance [USPS] staff, Company Call Centers, Company Field Staff, US Medical Information [USMI], US Quality Assurance [USQA], US Regulatory Affairs [USRA] and Global Drug Safety [GDS] colleagues.
Consumers, healthcare professionals, and other manufacturers.
1. Understand and adhere to USPS and GDS reporting obligations by initiating and processing adverse event reports within approved timelines as defined in local and global work instructions, SOPs and regulations to meet local and global reporting requirements.
2. Obtain detailed knowledge of FDA, EMEA and other regulatory authority regulations and apply information to daily work operations.
3. Receive, prioritize and accurately transfer information from initial and follow-up source documents of serious and non serious adverse event reports to the appropriate fields in ARISg, code adverse events using MedDRA, and accurately advance cases through ARISg workflow within global and local timelines.
4. Perform Case Initiation duties as assigned. This includes but is not limited to receiving and tracking information regarding potential initial and follow up adverse event reports from all sources, prioritizing and performing searches for duplicates in ARISg prior to the initiation of the case into ARISg, initiating adverse event reports into ARISg, providing reports to assigned staff members for assessment and assuring that cases are returned to case initiation for distribution within defined timelines.
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