Pharmacovigilance Job in Pune – Safety Science Coordinator I at Fortrea

Safety Science Coordinator I

Location: Pune, India
Job Type: Full-time
Application Deadline: August 20, 2025
Job ID: 254405

Fortrea is hiring a Safety Science Coordinator I to support Clinical Safety and Pharmacovigilance (PSS) operations. This role involves managing adverse event (AE) data from both clinical trials and post-marketing settings, ensuring compliance with regulatory requirements, and delivering high-quality safety services to clients.

Key Responsibilities

• Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) for clients, regulatory authorities, ethics committees, and investigators within agreed timelines.
• Maintain adverse event tracking systems and ensure accurate data entry.
• Write patient narratives and code adverse events using MedDRA.
• Conduct listedness assessments for marketed products.
• Generate and resolve queries for missing or discrepant safety information.
• Submit SAE reports to stakeholders including regulatory agencies and partners.
• Participate in database reconciliation and quality review of reports.
• Ensure compliance with SOPs, Work Instructions (WIs), and Quality Management System standards.
• Coordinate safety study files for archiving and arrange internal/external meetings.
• Mentor PSS Assistants or peers and build collaborative cross-functional relationships.

Qualifications

• Education: PharmD, MPharm, or BPharm with at least 2 years of relevant experience.
• Preferred background in Pharmacy, Nursing, Medical Sciences, or Life Sciences.
• Prior safety experience including AE/SAE processing, narrative writing, and regulatory submissions.
• Proficiency in English and local language (reading, writing, speaking).
• Skills in MS Office, attention to detail, and ability to handle multiple tasks in a fast-paced environment.

Why Join Fortrea?

This role offers the chance to work in a global CRO environment, gain hands-on experience in pharmacovigilance, and contribute to patient safety worldwide. You will collaborate with experts, handle end-to-end safety operations, and play a vital role in ensuring regulatory compliance.

📅 Apply by: August 20, 2025 – Don’t miss your chance to join Fortrea’s expert safety science team in Pune.

Interview Questions – Safety Science Coordinator I (Pharmacovigilance / Safety Science)

1. Domain Knowledge & Technical Skills

• Can you explain the difference between Adverse Event (AE) and Serious Adverse Event (SAE)?
• What are Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), and when are they required?
• How do you code adverse events using MedDRA? Can you walk me through the process?
• What is a listedness assessment and why is it important in pharmacovigilance?
• How do you ensure compliance with global regulatory reporting timelines (e.g., 7-day, 15-day reports)?
• What key details must be included in a patient narrative?
• Can you describe the ICH E2B guidelines for electronic reporting?
• How do you approach reconciliation of safety databases with clinical databases?

2. Process & Compliance

• What steps would you follow when receiving a new SAE report from a clinical site?
• How do you maintain accuracy and completeness in safety data entry?
• What is the role of a Quality Management System (QMS) in pharmacovigilance?
• How do you handle incomplete or discrepant AE information from a site?
• Can you explain your experience with SOPs and Work Instructions in your previous role?

3. Tools & Software

• Which safety databases have you worked with (e.g., Argus, ARISg, VigiBase)?
• How proficient are you with Microsoft Office tools, especially Excel for safety data tracking?
• How would you log and track adverse events in a database?

4. Regulatory & Guidelines Knowledge

• What do you know about ICH-GCP guidelines and their relevance to safety reporting?
• Can you give examples of regulatory reporting requirements for India (PvPI) and the EU (EudraVigilance)?
• How do post-marketing safety reports differ from clinical trial safety reports?

5. Behavioral & Situational

• Tell me about a time when you had to meet a very tight safety reporting deadline. How did you manage it?
• How do you handle high-volume safety case processing without compromising quality?
• Describe a time you had to work closely with a cross-functional team to resolve a safety issue.
• How do you stay updated on changes in pharmacovigilance regulations?

6. General & Career Motivation

• Why do you want to work with Fortrea in this Safety Science Coordinator role?
• How do you see your career growing in pharmacovigilance over the next 3–5 years?
• What qualities make someone successful in a safety science role?