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If you’re building a career in Pharmacovigilance (PV) and looking for a stable, growth-oriented role with a globally recognized organization, this opportunity could be the perfect next step. Syneos Health is currently hiring for the position of Safety & Pharmacovigilance Coordinator, based in Hyderabad, India.
This role is ideal for B.Pharm and M.Pharm graduates who already have hands-on experience in post-marketing surveillance (PMS) and spontaneous case processing and want to deepen their expertise in global drug safety operations. 🌍💊
About the Organization
The hiring organization is a global leader in biopharmaceutical solutions, supporting clinical development, medical affairs, and commercialization across the entire product lifecycle. With operations spanning more than 100 countries, the company works closely with pharmaceutical, biotechnology, and healthcare organizations worldwide.
What truly sets this organization apart is its people-first culture. Employees benefit from structured career development programs, continuous learning opportunities, and exposure to global safety projects. 🌱✨
Diversity, inclusion, and professional respect are embedded into everyday work life, making it a preferred employer in the pharmacovigilance domain.
Job Location & Work Model
- 📍 Primary Location: Hyderabad (Office-based)
- 📍 Additional Location Mentioned: Pune
- 💼 Employment Type: Full-time
- 🏢 Work Mode: On-site
This role is especially suitable for professionals who prefer a structured office environment and direct collaboration with cross-functional safety and regulatory teams.
Role Overview: Safety & Pharmacovigilance Coordinator
As a Safety & PV Coordinator, you will play a key role in ensuring patient safety and regulatory compliance throughout the drug lifecycle. Your daily responsibilities will focus on Individual Case Safety Reports (ICSRs), safety database management, and support of global pharmacovigilance activities.
The role requires strong attention to detail, regulatory awareness, and the ability to work efficiently under tight timelines — essential skills for long-term success in pharmacovigilance careers. 🧩📊
Key Responsibilities
📝 Case Processing & Safety Data Management
- Receive, track, and process ICSRs as per SOPs and project-specific safety plans
- Perform case triage and assess reports for completeness and regulatory reportability
- Enter and maintain safety data in validated safety databases
- Code adverse events, medical history, concomitant medications, and lab tests using standard dictionaries
📖 Narrative Writing & Follow-ups
- Prepare clear, accurate, and comprehensive case narratives
- Identify missing or unclear information and follow up with relevant stakeholders
⏱️ Regulatory Reporting
- Support preparation and submission of expedited safety reports
- Maintain safety tracking logs and documentation
📚 Additional Pharmacovigilance Activities
- Perform literature screening and safety reviews
- Support MedDRA coding, drug dictionary, and product coding
- Assist with xEVMPD submissions, including indication coding
- Handle duplicate case identification and reconciliation
- Participate in SPOR / IDMP-related activities
🗂️ Quality & Compliance
- Conduct quality reviews of ICSRs
- Ensure proper filing in TMF and PV System Master File
- Support internal and external audits when required
Eligibility & Qualifications
🎓 Education
- B.Pharm or M.Pharm only
💼 Experience
- Minimum 1 year of experience in:
- Post-Marketing Surveillance (PMS)
- Spontaneous case processing
💻 Technical Skills
- Experience with LSMV safety database preferred
- Candidates with Argus Safety experience are also welcome
- Strong knowledge of medical terminology and safety systems
📘 Regulatory Knowledge
- Understanding of ICH-GCP, GVP, and global PV regulations
- Familiarity with clinical trial phases II–IV and post-marketing safety
Skills That Make You Stand Out 🌟
- Excellent written and verbal communication skills 🗣️✍️
- Strong organizational and multitasking abilities
- High attention to detail and accuracy
- Ability to work independently and in cross-functional teams
- Proficiency in MS Word, Excel, PowerPoint, Outlook, and shared platforms
Why This Role Is a Great Career Move
Working as a Safety & Pharmacovigilance Coordinator provides exposure to real-world safety data, global regulatory requirements, and complex drug safety processes. This role builds a strong foundation for future growth into positions such as:
- Senior PV Associate
- Safety Scientist
- Pharmacovigilance Lead
If you’re passionate about patient safety and want to make an impact behind the scenes of drug development, this opportunity offers both purpose and long-term career growth. 📈🚀
Apply Now 👇🏻
Final Thoughts
The Safety & Pharmacovigilance Coordinator – Hyderabad position is a strong opportunity for early-career PV professionals. With the backing of a global organization, structured processes, and exposure to international safety operations, this role can be a career-defining move in pharmacovigilance. 💊❤️
