Fortrea is hiring for three full-time positions in India: Safety Science Coordinator I in Pune, Safety Science Coordinator II in Bangalore, and Librarian in Pune.

The Safety Science Coordinator roles support clinical safety and pharmacovigilance operations, including adverse event processing, safety reporting, regulatory submissions, tracking systems, and database reconciliation. The Librarian role focuses on biomedical literature searches and identifying safety information relevant to pharmacovigilance.

Job Details

1. Safety Science Coordinator I – Pune

Responsibilities

• Assist with processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
• Maintain adverse event tracking systems.
• Set up and maintain project and central documentation files.
• Process AE/SAE reports and enter safety data into tracking systems.
• Write patient narratives and accurately code adverse events using MedDRA, where applicable.
• Assist with listedness assessments against appropriate labels for marketed products.
• Generate queries for missing or discrepant information.
• Support expedited SAE submissions to clients, regulatory authorities, ethics committees, investigators, vendors, partners and project personnel.
• Support peer and quality review of processed reports.
• Assist with database reconciliation.
• Maintain files related to adverse event reporting requirements.
• Work within the Quality Management System, including SOPs and Work Instructions.
• Support safety study file preparation and archiving.
• Coordinate internal and external meetings/teleconferences.
• Train and mentor PSS Assistants or peers.
• Maintain relationships across functional units.
• Ensure compliance with regulatory requirements and study/project plans.
• Provide administrative support to PSS personnel.

Eligibility / Qualifications

Fortrea lists the following minimum pathways:

• Non-degree + 1–2 years of Safety experience or relevant experience.
• Associate degree + 6 months–1 year of Safety experience or relevant experience.
• BS/BA + 0–6 months to 1 year of Safety experience or relevant experience.
• MS/MA + 0–6 months of Safety experience or relevant experience.
• PharmD + 0–6 months of Safety experience or relevant experience.
• For PharmD candidates, a one-year residency or fellowship can be considered relevant experience.
• Preferred disciplines include Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.

Relevant experience may include pharmaceutical, biotechnology or CRO experience in areas such as Medical Affairs, Clinical Data Entry, Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs or Quality Assurance.

Required Skills

• Teamwork and peer support
• Ability to prioritize and manage multiple tasks
• Attention to detail
• Good written and verbal communication
• Logical and spelling skills
• Ability to proofread numerical data
• Good keyboard skills
• Knowledge of MS Office and Windows is beneficial

2. Safety Science Coordinator II – Bangalore

Responsibilities

• Process adverse event reports from various sources according to client/sponsor plans.
• Manage receipt and processing of spontaneous and clinical-trial adverse event reports.
• Enter safety data into adverse event databases and tracking systems.
• Review adverse events for completeness, accuracy and appropriateness for expedited reporting.
• Write patient narratives and code adverse events using MedDRA, where applicable.
• Determine listedness against the appropriate label for marketed products.
• Identify missing clinically significant information and generate queries.
• Ensure appropriate medical review of cases.
• Prioritize cases requiring expedited reporting within applicable timelines.
• Submit expedited SAE reports to relevant recipients as required.
• Process ESRs and PSRs.
• Maintain tracking systems and project documentation.
• Support quality or peer review of processed reports.
• Assist with database reconciliation.
• Support training and mentoring of PSS staff.
• Support monthly status reports and PSS metrics.
• Maintain knowledge of SOPs, Work Instructions, guidance documents and directives related to safety management and reporting.
• Assist with client meetings and liaise with client contacts where appropriate.
• Support quality issue management and audit/inspection preparation.
• Ensure compliance with regulatory requirements and study/project plans.

Eligibility / Qualifications

• Non-degree + 1 year Safety experience or 3 years relevant experience.
• Associate degree + 1 year Safety experience or 2 years relevant experience.
• BS/BA + 1 year relevant experience.
• MS/MA + 1 year relevant experience.
• PharmD + 1 year relevant experience.
• For PharmD candidates, a one-year residency or fellowship can be considered relevant experience.
• Preferred disciplines include Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.

Required Skills

• High degree of accuracy and attention to detail
• Teamwork and peer support
• Good written and verbal communication
• Ability to work independently with moderate supervision
• Good keyboard skills
• Knowledge of MS Office and Windows applications is beneficial
• Mentoring skills preferred

3. Librarian – Pune

Role Overview

The Librarian will support the pharmacovigilance team by conducting systematic literature searches to identify safety signals, adverse drug reactions and emerging safety information.

Responsibilities

• Design and execute literature searches using PubMed, Embase, Scopus and Web of Science.
• Monitor and retrieve publications relevant to Individual Case Safety Reports (ICSRs), PSURs and DSURs.
• Document search strategies, results and rationale for regulatory audits and inspections.
• Collaborate with pharmacovigilance scientists, medical writers and regulatory affairs teams.
• Stay current with Good Pharmacovigilance Practices (GVP), particularly Module VI, and other global safety regulations.

Eligibility / Qualifications

• Master’s degree in Library Science, Information Management, or a related field.
• Minimum 2 years of experience in biomedical literature searching, preferably in a pharmaceutical or healthcare setting.
• Familiarity with medical indexing systems such as MeSH and Emtree.
• Knowledge of Boolean logic.
• Understanding of pharmacovigilance principles and regulatory frameworks including EMA, FDA and ICH.
• Strong attention to detail and ability to manage multiple priorities under tight deadlines.

Preferred Skills

• Experience with reference management tools such as EndNote or Mendeley.
• Knowledge of drug safety databases and signal detection methodologies.
• Certification in pharmacovigilance or drug safety is a plus.
• Strong analytical skills.
• Excellent written and verbal communication skills.

Application Details

Application Link for Safety Science Coordinator I – Pune

Application Link for Safety Science Coordinator II – Bangalore

Application Link for Librarian – Pune