About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

The purpose of this role is to provide for the timely initiation, tracking, data entry, and follow up of adverse event reports received for marketed products according to Company SOPs, Federal, Regulations and global and local quality documents.

Key Tasks & Responsibilities

• 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.
• Receive, prioritize and accurately transfer information from initial and follow-up source documents of 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.
• Perform Triage and 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.
• Collect accurate follow up information in a timely manner on non-serious and other adverse event reports.
• Communicate with other manufacturers, legal, USMI, USQA, and RA regarding actions to be taken for adverse event reports, as directed.
• Understand and utilize labeled information for all EMD Serono marketed products.
• Collaborate in the review of written materials including data collection, tracking tools, and other documents as assigned.
• Contribute to the development of the team by participating in training programs, staff presentations and working groups.
• Participate in internal and external training programs, meetings, and conferences to continually improve and build a knowledge base of product safety and risk management.