Fortrea has announced an opening for a Safety Science Specialist in Bangalore for professionals interested in building their careers in pharmacovigilance, drug safety and clinical safety operations.
This role is particularly relevant for candidates with educational backgrounds in Pharmacy, Biological Sciences, Nursing, Medical Sciences, Life Sciences or related disciplines and prior experience in pharmacovigilance or related pharmaceutical/CRO functions.
The Safety Science Specialist will support end-to-end adverse event processing, including AE/SAE case processing, safety database entry, MedDRA coding, patient narrative writing, follow-up activities, expedited safety reporting and regulatory submissions.
Candidates with experience in related functions such as Clinical Data Management, Regulatory Affairs, Quality Assurance, Medical Affairs and Clinical Data Monitoring may also be considered, subject to Fortrea’s experience requirements.
Job Overview
As a Safety Science Specialist at Fortrea, you will assist with Clinical Safety and/or Patient Safety Services (PSS) operations associated with investigational and marketed products.
The position involves managing adverse event information received from clinical trials and post-marketing sources and ensuring that reportable safety cases are processed and submitted within applicable regulatory and study-specific timelines.
The role requires strong attention to detail, understanding of pharmacovigilance processes and the ability to maintain high standards of safety data quality.
Key Responsibilities
The selected candidate will be responsible for:
- Receiving and processing adverse event reports from spontaneous, solicited and clinical trial sources.
- Entering safety information into adverse event databases and tracking systems.
- Reviewing AE/SAE reports for completeness, accuracy and suitability for expedited reporting.
- Writing accurate and medically appropriate patient safety narratives.
- Coding adverse events using MedDRA terminology.
- Determining listedness against the applicable product label for marketed products, where required.
- Identifying clinically significant missing information and supporting follow-up activities.
- Preparing follow-up correspondence in consultation with medical staff.
- Ensuring cases receive appropriate medical review.
- Processing cases requiring expedited reporting within applicable timelines.
- Supporting submission of Serious Adverse Event (SAE) reports to regulatory authorities, ethics committees, investigators, clients, partners and other applicable stakeholders.
- Assisting with safety database reconciliation in collaboration with Data Management teams or clients.
- Supporting processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintaining adverse event tracking systems, project documentation and central safety files.
- Performing quality or peer review of processed safety reports.
- Maintaining knowledge of pharmacovigilance SOPs, Work Instructions, guidance documents and safety reporting requirements.
- Assisting with PSS metrics and preparation for client meetings.
- Supporting Safety Committees and Data Safety Monitoring Boards (DSMBs), where applicable.
- Coordinating safety study files for archiving following project completion.
- Supporting Root Cause Analysis (RCA) and CAPA development for identified quality issues.
- Supporting audits and regulatory inspections.
Qualification & Eligibility
Fortrea prefers candidates with a degree in one or more of the following areas:
B.Pharm / M.Pharm / Pharm.D / Biological Sciences / Life Sciences / Nursing / Medical Sciences or a related discipline.
Candidates should note that the required experience varies according to educational qualification.
| Education | Minimum Experience |
|---|---|
| Non-degree | 2 years safety experience OR 3–4 years relevant experience |
| Associate Degree | 2 years safety experience OR 2–3 years relevant experience |
| BS/BA / Bachelor’s Degree | 1 year safety experience OR 2 years relevant experience |
| MS/MA / Master’s Degree | 1 year safety experience OR 1–2 years relevant experience |
| Pharm.D | 1 year safety experience OR 1–2 years relevant experience |
For Pharm.D candidates, Fortrea states that a one-year residency or fellowship may be considered relevant experience.
Therefore, this is not primarily a fresher pharmacovigilance opening. Candidates generally need at least 1 year of safety experience, or the applicable amount of relevant pharmaceutical, biotechnology or CRO experience depending on their qualification.
What Counts as Safety Experience?
According to the job description, safety experience includes practical experience with activities such as:
- AE/SAE case processing
- Patient narrative generation
- Safety queries and follow-up
- Working with pharmacovigilance/safety databases
- Regulatory safety submissions
This makes the Fortrea Safety Science Specialist position particularly suitable for professionals already working in Drug Safety, Pharmacovigilance, ICSR Processing or Clinical Safety.
Candidates From Related Domains Can Also Apply
An important feature of this opening is that Fortrea recognizes certain related pharmaceutical and clinical research experience.
Relevant experience may include work in:
- Medical Affairs
- Clinical Data Entry
- Clinical Data Management
- Clinical Data Monitoring
- Regulatory Affairs
- Quality Assurance
- Pharmaceutical industry
- Biotechnology industry
- CRO environments
Fortrea may also consider relevant and equivalent experience in place of certain educational requirements.
Key Skills Required
Candidates applying for the Fortrea Safety Science Specialist job in Bangalore should have:
- Knowledge of pharmacovigilance and clinical safety processes
- AE and SAE case-processing knowledge
- MedDRA coding knowledge
- Patient narrative writing skills
- Understanding of expedited safety reporting
- Knowledge of regulatory safety submissions
- Strong attention to detail and accuracy
- Good written and verbal communication skills
- Ability to work effectively as part of a team
- Ability to work independently with minimal supervision
- Knowledge of Microsoft Office and Windows applications
- Good presentation skills
- Training and mentoring capabilities are preferred
Why Consider This Opportunity?
The Safety Science Specialist role provides exposure to several important areas of global pharmacovigilance operations, including ICSR processing, expedited reporting, regulatory submissions, safety database management, quality review, CAPA, audits and inspections.
Professionals looking to deepen their expertise in clinical safety and pharmacovigilance can gain experience working across different stakeholders, including regulatory authorities, ethics committees, investigators, clients, partners and internal project teams.
The job description indicates that the working environment may be office-based or remote, depending on applicable business and project requirements.
Who Should Apply?
This opportunity may be suitable for:
B.Pharm, M.Pharm, Pharm.D and eligible Life Science professionals with prior pharmacovigilance experience, especially candidates experienced in AE/SAE processing, ICSR case processing, MedDRA coding, narratives, safety databases and regulatory submissions.
Professionals from Clinical Data Management, Regulatory Affairs, Medical Affairs, Clinical Monitoring and Quality Assurance may also be eligible if they meet the specified relevant-experience criteria.
How to Apply
