Fortrea, a global contract research organization (CRO), is at the forefront of transforming drug and device development. With decades of clinical development experience and operations in over 100 countries, Fortrea provides pharmaceutical, biotechnology, and medical device clients with innovative clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Below, we explore three exciting roles at Fortrea: Regulatory Operations Assistant I, Safety Science Coordinator I, and Safety Science Analyst.
Regulatory Operations Assistant I (Hybrid, Pune)
Responsibilities
- Prepare, compile, and review regulatory documents supporting product development and submissions worldwide.
- Revise raw material and packaging specifications.
- Collaborate with cross-functional teams for change control evaluation and document management.
- Manage tasks like supplier data management, PO creation, and financial data maintenance.
- Support global labeling document creation and stability data evaluation.
- Conduct literature surveys for regulatory documentation.
- Maintain quality standards for laboratory support and assist in system validation and upgrades.
- Ensure compliance with regulatory guidelines and maintain efficient processes.
Qualifications
- Bachelor’s degree in pharmacy, science, or a related field.
- Knowledge of regulatory guidelines and pharmaceutical product lifecycle management.
- Strong analytical and organizational skills.
Skills
- Attention to detail.
- Proficiency in documentation and compliance standards.
- Effective teamwork and communication abilities.
Safety Science Coordinator I (Full-time, Pune)
Responsibilities
- Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and project files.
- Report adverse events to clients, regulatory authorities, and other stakeholders within study timelines.
- Ensure quality data entry using MedDRA and assist in narrative writing.
- Conduct quality reviews of reports and assist with database reconciliation.
- Provide administrative support and coordinate meetings/teleconferences.
- Train and mentor team members.
Qualifications
- Bachelor’s degree in life sciences, pharmacy, or a related field.
- Experience in safety science operations or pharmacovigilance.
- Familiarity with adverse event reporting requirements and MedDRA.
Skills
- Strong communication and coordination capabilities.
- Competence in data management and quality control.
- Ability to work collaboratively across teams.
Safety Science Analyst (Full-time, Pune)
Responsibilities
- Manage case intake, triage, and adverse event data processing.
- Write patient narratives and accurately code adverse events.
- Submit expedited reports to regulatory authorities, clients, and stakeholders.
- Maintain compliance with regulatory timelines and reconcile databases.
- Provide support for adverse event documentation and archival processes.
- Foster strong relationships across functional units.
Qualifications
- Bachelor’s degree in a relevant field.
- Knowledge of safety data systems and regulatory reporting.
- Experience in adverse event case management and narrative writing.
Skills
- Attention to detail and accuracy in data handling.
- Proficiency in MedDRA and safety reporting tools.
- Strong organizational and multitasking abilities.
Application Link Safety Science Analyst
Application Link Regulatory Operations Assistant I
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Application Link Safety Science Coordinator I
