Fortrea Pharmacovigilance Safety Specialist I

Fortrea Clinical Safety Specialist I Jobs in Bangalore – Pharmacovigilance Careers for Pharmacy & Life Sciences Graduates

Fortrea is hiring for the position of Specialist I – Clinical Safety in the Clinical Pharmacovigilance and Drug Safety department at its Bangalore location. This opportunity is designed for professionals with educational backgrounds in pharmacy, life sciences, biological sciences, nursing, or medical sciences who are interested in building careers in pharmacovigilance, adverse event case processing, and clinical trial safety monitoring.

The position focuses on managing adverse event (AE) and serious adverse event (SAE) reporting activities generated from clinical trials and post‑marketing safety sources. Professionals with 1–2 years of pharmacovigilance experience or relevant pharmaceutical/CRO experience will find this role suitable for advancing their careers in the global drug safety and clinical research industry.

This role is based in Bangalore, India, within Fortrea’s clinical safety operations team and offers exposure to global regulatory safety reporting, clinical trial monitoring, and pharmacovigilance database management used across international pharmaceutical programs.

Company Overview

Fortrea is a global contract research organization (CRO) specializing in clinical development, patient safety monitoring, regulatory support, and data management services for pharmaceutical, biotechnology, and medical device companies.

The organization supports drug development across the full clinical lifecycle including clinical trials, pharmacovigilance operations, regulatory submissions, and post‑marketing safety surveillance. By partnering with global pharmaceutical sponsors, Fortrea ensures medicines are developed and monitored according to international regulatory standards.

Fortrea’s clinical safety teams play a vital role in monitoring drug safety, managing adverse event reports, and ensuring timely regulatory reporting to health authorities worldwide. The company operates in a highly regulated environment guided by ICH guidelines, Good Clinical Practice (GCP), and global pharmacovigilance regulations.

Professionals working at Fortrea gain exposure to multinational clinical trials, global drug safety databases, and regulatory reporting frameworks that support the safe use of medicines worldwide.

Job Role and Responsibilities

The Specialist I – Clinical Safety supports pharmacovigilance and patient safety operations related to clinical trials and marketed pharmaceutical products. The role focuses on case processing, safety database management, and regulatory reporting activities within global drug safety programs.

Adverse Event Case Processing

• Receive and process adverse event reports collected from clinical trials or spontaneous post‑marketing sources

• Enter safety data into pharmacovigilance databases and tracking systems

• Review adverse event cases for completeness, accuracy, and regulatory reporting requirements

• Write clear and accurate patient narratives based on safety case information

• Code adverse events using MedDRA terminology

• Identify missing safety information and initiate follow‑up queries where necessary

Regulatory Safety Reporting

• Process and submit Serious Adverse Event (SAE) reports within regulatory timelines

• Support submission of safety reports to clients, regulatory authorities, ethics committees, investigators, and study partners

• Prepare and support submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)

• Assist with preparation of safety listings for Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)

Safety Data Management

• Maintain safety tracking systems and pharmacovigilance databases

• Perform reconciliation activities with clinical data management teams or sponsors

• Maintain project files and central safety documentation records

• Ensure documentation readiness for audits and regulatory inspections

Signal Detection and Safety Monitoring

• Participate in safety signal detection activities and pattern recognition

• Support preparation of safety metrics and monthly safety reports

• Assist with cumulative safety data reviews required for regulatory reporting

Compliance and Quality Management

• Follow pharmacovigilance Standard Operating Procedures (SOPs) and Work Instructions

• Assist in updating Safety Management Plans and reconciliation procedures

• Support audit and inspection readiness activities

• Contribute to root cause analysis and CAPA implementation when required

Collaboration and Team Support

• Participate in project meetings and discussions with clients and internal teams

• Provide support and guidance to junior pharmacovigilance staff

• Coordinate with cross‑functional teams including data management and regulatory affairs

• Ensure high‑quality service delivery for both internal and external stakeholders

Through these responsibilities, the Specialist I role contributes to ensuring patient safety, regulatory compliance, and accurate safety monitoring throughout the clinical development process.

Eligibility and Qualifications

Candidates interested in applying for the Specialist I – Clinical Safety role should meet the following academic and professional requirements.

Educational Qualification

Bachelor’s, Master’s, or PharmD degree in relevant scientific disciplines.

Relevant educational backgrounds include:

BPharmacy, MPharmacy, PharmD, BSc Life Sciences, BSc Nursing, MSc Biotechnology, MSc Microbiology, MSc Biochemistry, MSc Pharmacology, MSc Clinical Research, MSc Life Sciences, Biological Sciences.

Experience

• 1–2 years of pharmacovigilance or drug safety experience including AE/SAE case processing

OR

• 2–5 years of experience in pharmaceutical, biotechnology, or CRO environments such as clinical data management, regulatory affairs, medical affairs, or quality assurance

Technical Skills

• Experience processing adverse event and serious adverse event reports

• Knowledge of MedDRA coding and patient narrative writing

• Understanding of pharmacovigilance safety databases

• Familiarity with Good Clinical Practice (GCP) guidelines

• Knowledge of ICH pharmacovigilance regulations and global safety reporting requirements

• Experience supporting safety reports such as PSUR and DSUR

Professional Skills

• High attention to detail and data accuracy

• Strong written and verbal communication abilities

• Ability to work independently with minimal supervision

• Good teamwork and collaboration skills

• Strong organizational and documentation skills

Professionals experienced in pharmacovigilance case processing, clinical trial safety documentation, regulatory safety reporting, and drug safety surveillance will find this role well aligned with long‑term careers in clinical research and global CRO organizations.

Location and Salary

Location: Bangalore, Karnataka, India

Work Environment: Office‑based clinical safety operations role

Salary: Competitive salary package based on experience and CRO industry standards.

Employees working with Fortrea gain exposure to global drug safety operations, regulatory pharmacovigilance frameworks, and international clinical research programs.

Application Process

Candidates interested in applying for the Specialist I – Clinical Safety role can submit their application through the official Fortrea careers portal.

Apply Here:

https://careers.fortrea.com/us/en/job/26731/Specialist-I

Applicants are encouraged to apply early as pharmacovigilance roles within global CRO organizations typically receive a high number of qualified applications.

Frequently Asked Questions

What does a Clinical Safety Specialist do?

A Clinical Safety Specialist manages adverse event reports, performs pharmacovigilance case processing, writes patient narratives, and ensures regulatory safety reporting compliance during clinical trials and post‑marketing drug monitoring.

Who can apply for the Fortrea Specialist I role?

Candidates with degrees in pharmacy, life sciences, biotechnology, nursing, or medical sciences with pharmacovigilance or clinical research experience can apply.

What is AE and SAE processing in pharmacovigilance?

AE and SAE processing involves reviewing safety reports, entering case data into pharmacovigilance systems, coding medical terms using MedDRA, and reporting safety events to regulatory authorities.

What regulatory guidelines are important for this role?

Knowledge of Good Clinical Practice (GCP), ICH pharmacovigilance guidelines, and global regulatory reporting requirements is important for performing drug safety operations.

Where is the job located?

The role is located in Bangalore, India, within Fortrea’s clinical safety and pharmacovigilance operations team.

Job Summary

Category	Details
Company	Fortrea
Vacancies	Specialist I – Clinical Safety
Required Education	BPharmacy, MPharmacy, PharmD, BSc Life Sciences, BSc Nursing, MSc Biotechnology, MSc Microbiology, MSc Biochemistry, MSc Pharmacology, MSc Clinical Research, MSc Life Sciences
Experience	1–2 years Pharmacovigilance or 2–5 years Pharmaceutical/CRO experience

Tagged as: Pharma Jobs in Bangalore