Fortrea Hiring Safety Science Coordinator I

Fortrea Hiring Safety Science Coordinator I | Pharmacovigilance Jobs Pune | Apply Now

Fortrea is hiring for the position of Safety Science Coordinator I in Pune. This full-time opportunity is ideal for candidates with 2+ years of experience in pharmacovigilance, clinical safety, or adverse event processing. The role focuses on handling adverse event reporting, safety data management, and regulatory submissions within clinical trials and post-marketing environments.

This is a strong opportunity for professionals from pharmacy and life sciences backgrounds to advance their careers in drug safety, clinical research, and global pharmacovigilance operations.

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Company Overview

Fortrea is a leading global contract research organization (CRO) specializing in clinical development, patient access, and pharmacovigilance services. The company supports pharmaceutical, biotechnology, and medical device organizations in accelerating drug development and ensuring patient safety.

With a strong global presence and expertise in clinical trials and regulatory compliance, Fortrea plays a key role in advancing healthcare innovations. The organization provides end-to-end clinical and safety solutions, making it a preferred partner for life sciences companies worldwide.

Working at Fortrea offers exposure to global clinical safety systems, regulatory frameworks, and advanced pharmacovigilance operations.

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Job Role & Responsibilities

As a Safety Science Coordinator I, you will support clinical safety operations and manage adverse event reporting processes across clinical trials and post-marketing settings.

Key Responsibilities:

• Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)
• Maintain adverse event (AE) tracking systems and safety databases
• Perform data entry and ensure accurate documentation of safety data
• Write patient safety narratives and code adverse events using MedDRA
• Assist in listedness assessment for marketed products
• Generate queries for missing or inconsistent safety data
• Submit SAE reports to regulatory authorities, ethics committees, and stakeholders within timelines
• Support reconciliation of safety databases and tracking systems
• Maintain regulatory documentation and safety reporting files
• Assist in quality review of processed safety reports
• Support project file management and archiving activities
• Coordinate meetings and communication across project teams
• Ensure compliance with SOPs, regulatory guidelines, and quality management systems
• Provide administrative and operational support to pharmacovigilance teams

This role is critical in ensuring accurate safety data processing and compliance with global regulatory requirements.

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Eligibility / Qualifications

Educational Qualification:

Candidates must have a degree in pharmacy or life sciences

Eligible qualifications include:

B.Pharm, M.Pharm, Pharm.D, B.Sc Nursing, M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, Medical Sciences

Experience:

• Minimum 2 years of experience in clinical trial safety or pharmacovigilance

Required Experience Includes:

• Processing AE/SAE reports
• Writing narratives and managing safety databases
• Handling regulatory submissions and safety reporting workflows

Skills Required:

• Strong understanding of pharmacovigilance and clinical safety processes
• Knowledge of MedDRA coding and safety databases
• Excellent attention to detail and data accuracy
• Strong communication and documentation skills
• Ability to manage multiple tasks and deadlines
• Good analytical and problem-solving skills
• Proficiency in MS Office and basic computer systems

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Location & Salary

• Job Location: Pune, India
• Job Type: Full-Time
• Department: Pharmacovigilance / Clinical Safety
• Salary: Competitive salary package based on experience and industry standards

Fortrea offers strong career growth opportunities in clinical research, drug safety, and regulatory compliance.

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Application Process

Interested candidates can apply directly through the official job portal:

Apply Here: https://fortrea.wd1.myworkdayjobs.com/Fortrea/job/Pune/Safety-Science-Coordinator-I_261492

Ensure your resume highlights pharmacovigilance experience, adverse event processing, and regulatory submission expertise.

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Why Join Fortrea?

• Work with a leading global CRO in clinical research and pharmacovigilance
• Exposure to international clinical trials and safety systems
• Opportunity to build expertise in drug safety and regulatory compliance
• Strong learning and career growth opportunities
• Collaborative work environment with global teams

This role is ideal for professionals looking to build long-term careers in pharmacovigilance and clinical safety operations.

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Frequently Asked Questions (FAQs)

1. What experience is required for this role?

Candidates must have at least 2 years of experience in pharmacovigilance or clinical safety.

2. Is MedDRA knowledge required?

Yes, knowledge of MedDRA coding and adverse event processing is important.

3. What qualifications are eligible?

Candidates with pharmacy or life sciences degrees such as B.Pharm, M.Pharm, or Pharm.D are eligible.

4. What type of work will I handle?

You will manage adverse event reporting, safety data processing, and regulatory submissions.

5. Where is the job located?

The position is based in Pune, India.

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Summary Table

Category	Details
Company	Fortrea
Vacancies	Safety Science Coordinator I
Required Education	B.Pharm, M.Pharm, Pharm.D, B.Sc Nursing, M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research
Experience	Minimum 2 Years in Pharmacovigilance / Clinical Safety