other
Posted 14 hours agoSafety Science Analyst
at Fortrea
Mumbai, IndiaRemote
Responsibilities
- Manage and process expeditable adverse events to the required standard and submit them to the client and/or the regulatory agencies (if required) within the agreed/stated timelines.
- Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable).
- Support upload/archival of case/study/project documentation, as appropriate.
- Build and maintain good PSS relationships across functional units.
- Support compliance of operations with governing regulatory requirements.
- Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial.
Requirements
- Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.
- Qualifications (Minimum Required): Non-Degree or 6 months - 1 year of Safety experience or relevant experience *
- Associate Degree with 0-6 months of Safety experience or relevant experience*
- BS/BA with 0- 6 months of Safety experience or relevant experience*
- MS/MA with 0 yrs. of Safety experience or relevant experience*
- Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements.
- To be used in lieu of experience, Degree required to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area *Safety experience includes actual
- experience of processing AE/SAE reports, generating narratives, queries, working within safety databases, and
- experience with regulatory submissions. *
- experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
- Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.
- Knowledge of MS office Windows applications beneficial.
Additional details
- Job Overview: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports).
- Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business.
- Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and costeffective manner.
- The role will be expected to comply with the legal
- requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary of
- Assist with processing of the adverse events, including but not limited to: Data entry of safety data onto adverse event tracking systems.
- Assist in the listedness assessment against appropriate label (for Marketed products, if applicable).
- Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed.
- Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines.
- Assist in the reconciliation of databases, as applicable.