[Hiring] Safety Science Coordinator I @Fortrea

Role Description

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). Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as a stand-alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. He/she 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.

Qualifications

• Non-Degree or 1-2 years of Safety experience or relevant experience
• Associate degree or 6 months to 1 year of Safety experience or relevant experience
• BS/BA with 0-6 months to 1 year of Safety experience or relevant experience
• MS/MA with 0-6 months of Safety experience or relevant experience
• PharmD with 0-6 months of Safety experience or relevant experience
• For PharmD, a one-year residency or fellowship can be considered as relevant experience. To be considered in lieu of experience, Degree preferred 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 processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
• Relevant experience includes 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.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Speaking: English and local language.
• Writing/Reading: English and local language.

Requirements

• Good team player and offer peer support as needed.
• Ability to set priorities and handle multiple tasks.
• Attention to detail.
• Good written and verbal communication skills.
• Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical data.
• Good keyboard skills, preferably with knowledge of MS Office and Windows would be beneficial.
• Ability to operate standard office equipment.

Benefits

• Office Environment or remote.