Fortrea is hiring for the position of Safety Science Coordinator I in Pune, India. The role focuses on clinical safety and pharmacovigilance operations, including adverse event processing, safety report preparation, regulatory submissions, and safety database maintenance.
Candidates with backgrounds in Life Sciences, Pharmacy, Nursing, Medical Sciences, or related disciplines and relevant safety or pharmaceutical industry experience can review the eligibility criteria.
Job Details
| Particulars | Details |
|---|---|
| Company | Fortrea |
| Job Title | Safety Science Coordinator I |
| Job Requisition ID | 265644 |
| Location | Pune, India |
| Job Type | Full-time |
| Work Environment | Office |
| Job Category | Clinical Safety / Pharmacovigilance |
Position: Safety Science Coordinator I
The selected candidate will support Patient Safety Services (PSS) and clinical safety operations, processing adverse event reports from clinical trials and post-marketing sources while maintaining data quality and regulatory compliance.
Job Responsibilities
- Assist with processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and project documentation files.
- Log incoming Adverse Event (AE) and Serious Adverse Event (SAE) reports in departmental tracking applications.
- Perform safety data entry and prepare patient narratives.
- Code adverse events using MedDRA, where applicable.
- Assist with listedness assessments for marketed products, where applicable.
- Generate queries to collect missing or inconsistent information in consultation with medical staff.
- Support submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, vendors, and other relevant stakeholders.
- Assist with quality reviews of processed reports and database reconciliation.
- Maintain documentation related to adverse event reporting requirements.
- Follow Standard Operating Procedures (SOPs), departmental Work Instructions (WIs), and applicable regulatory requirements.
- Coordinate safety study file archiving at project completion.
- Arrange internal and external meetings or teleconferences.
- Support and mentor Patient Safety Services assistants or peers.
- Maintain data quality and provide administrative support to PSS personnel.
Eligibility and Qualifications
Fortrea lists the following educational and experience pathways:
- Life Sciences graduates: 1–2 years of safety or relevant experience.
- Associate degree holders: 6 months to 1 year of safety or relevant experience.
- BS/BA graduates: 0–6 months to 1 year of safety or relevant experience.
- MS/MA graduates: 0–6 months of safety experience.
- PharmD graduates: 0–6 months of safety experience.
For PharmD candidates, a one-year residency or fellowship may be considered relevant experience.
Preferred degree disciplines include:
- Biological Sciences
- Pharmacy
- Nursing
- Medical Sciences
- Life Sciences
- Related disciplines
Fortrea may consider relevant and equivalent experience in place of educational requirements.
Relevant safety experience includes processing AE/SAE reports, preparing patient narratives and queries, working with safety databases, and handling regulatory submissions.
Other relevant industry experience may include work in pharmaceutical, biotechnology, or CRO organisations in Medical Affairs, Clinical Data Entry, Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
Required Skills
Candidates should demonstrate:
- Teamwork and peer support.
- Ability to prioritise and manage multiple tasks.
- Attention to detail.
- Strong written and verbal communication skills.
- Logical thinking, spelling accuracy, and proofreading ability.
- Accuracy when handling numerical data.
- Good keyboard skills.
- Familiarity with MS Office and Windows.
- Ability to operate standard office equipment.
- English and local-language speaking, reading, and writing skills.
