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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5. Collect accurate follow up information in a timely manner on non-serious and other adverse event reports.
6. Communicate with other manufacturers, legal, USMI, USQA, and RA regarding actions to be taken for adverse event reports, as directed.
7. Understand and utilize labeled information for all EMD Serono marketed products.
8. Collaborate in the review of written materials including data collection, tracking tools, and other documents as assigned.
9. Contribute to the development of the team by participating in training programs, staff presentations and working groups.
10. Participate in internal and external training programs, meetings, and conferences to continually improve and build a knowledge base of product safety and risk management.
11. Other job duties as assigned.
Degree in a life science or health profession licensure (Nurse, Pharmacist, Nurse Practitioner, etc.) with a minimum of 1 year of experience in Drug Safety or a pharmaceutical company and/or a minimum of 3 to 5 years experience in a healthcare setting.
Detailed knowledge of FDA, EMEA and other regulatory authority regulations.
PROFESSIONAL SKILLS & EXPERIENCE
Good organizational skills with the ability to multi-task and follow projects to completion
Experience with database applications (ARISg, Excel, Microsoft Word, etc.) and excellent data entry skills.
PERSONAL SKILLS & COMPETENCIES
Ability to effectively communicate with consumers and healthcare professionals.
Ability to work effectively as a member of a dynamic team.
Experience: 3-5 Years
Education: B.Pharm, M.Pharm, BS, MS - Life Sciences
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 21st Nov., 2011
Job ID: 1102965
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