Are you passionate about ensuring safety in every aspect of a dynamic and innovative work environment? Fortera is on the lookout for a skilled Safety Science Analyst to join our growing team. As a key player in our commitment to safety excellence, you’ll have the opportunity to make a meaningful impact while working alongside industry experts and contributing to groundbreaking projects.
Discover a career that goes beyond the ordinary — at Fortera, we prioritize safety, innovation, and teamwork. If you’re ready to take on a challenging role where your skills are valued and your contributions matter, we invite you to explore the exciting opportunities within our Safety Science team as Safety Science Analyst.
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Job Description
1. These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*.
2. Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial.
3. Assist with processing of the adverse events, including but not limited to:
a) Data entry of safety data onto adverse event tracking systems.
b) Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable).
c) Assist in the listedness assessment against appropriate label (for Marketed products, if applicable).
d) Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed.
e) Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Company project personnel, as required within the agreed timelines.
f) Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and company project personnel etc), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines.
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