Fortrea Hiring Safety Science Analyst

Fortrea Hiring Safety Science Analyst in Pune, India

Embarking on a career as a Safety Science Analyst is more than just a job; it’s a commitment to safeguarding the well-being of patients. Fortrea, located in the vibrant city of Pune, India, offers an exciting opportunity for individuals ready to make a difference in drug safety.

The Role of a Safety Science Analyst

Summary of Responsibilities:

• Perform case intake and triage of incoming safety information or reports from various sources, spontaneously or from a clinical trial.
• Assist with processing of the adverse events, including but not limited to:
• Data entry of safety data onto adverse event tracking systems.
• Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable).
• Assist in the listedness assessment against appropriate labels (for Marketed products, if applicable).
• Assist in generating queries and collecting missing or discrepant information in consultation with medical staff, if needed.
• 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.
• Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators, 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.
• Work within the Quality Management System framework, including, but not limited to, Standard Operating Procedures (SOPs), departmental Work Instructions (WIs), etc., as appropriate.
• If applicable, assist in maintaining supporting files/ documentation regarding adverse event reporting requirements in all countries.
• 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.
• All other duties as needed or assigned.

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**
• PharmD with 0 yrs. of Safety experience* or relevant experience**
• Fortrea may consider relevant and equivalent experience instead of educational requirements.
• To be used instead of experience, a Degree is required to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or r related area *Safety experience includes experience in processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
• ** Relevant experience includes work in the pharmaceutical, biotechnology, or CRO industry in related areas such as Medical Affairs, Clinical Data Entry and Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.

Safety Science Analyst

• Locations: Pune, India
• Time Type: Full-time
• Job Requisition ID: 2363078

These statements describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.

Fortrea is proud to be an Equal Opportunity Employer:

Fortrea is an Equal Opportunity Employer (EOE) that values diversity and inclusion. We are committed to fostering a workplace that is free from harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without discrimination based on race, religion, colour, national origin, gender, pregnancy, family or parental status, marital status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage candidates from all backgrounds to apply and join our diverse and inclusive workforce.

How to Apply for the Safety Science Analyst Position

Are you ready to embark on a fulfilling career journey with Fortrea?

Application Link

Tagged as: Global Pharma Jobs, Good Clinical Practice (GCP), Pharmaceutical Careers, Pharmaceutical Jobs