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Syneos Health, one of the world’s largest biopharmaceutical solutions organizations, is hiring for multiple roles in Gurugram, India. These openings include:
- Safety & Pharmacovigilance (PV) Coordinator
- Regulatory Associate
- Medical Writer I
- Clinical Research Associate (CRA)
With a presence across 110 countries and 29,000+ employees, Syneos Health has supported 94% of FDA-approved drugs in the last 5 years. This is an excellent opportunity for freshers and early-career professionals in life sciences, pharmacy, nursing, and related fields.
📝 Job Roles & Responsibilities
1️⃣ Safety & Pharmacovigilance (PV) Coordinator
- Manage ICSRs, perform MedDRA coding, and assist in expedited safety reports.
- Support query follow-ups, literature screening, and TMF documentation.
- Ensure compliance with ICH-GCP, GVP, and sponsor guidelines.
2️⃣ Regulatory Associate
- Assist in IND, NDA, MAA, DMF, and lifecycle submissions.
- Conduct regulatory research, gap analyses, and quality checks.
- Collaborate with cross-functional teams for timely submissions.
3️⃣ Medical Writer I
- Draft and edit clinical study protocols, CSRs, patient narratives, IBs.
- Ensure compliance with ICH-E3 and client templates.
- Conduct literature searches and review statistical analysis outputs.
4️⃣ Clinical Research Associate (CRA)
- Conduct on-site and remote monitoring of clinical studies.
- Ensure data accuracy, source verification, and protocol compliance.
- Train and mentor junior team members on monitoring practices.
- Maintain strong site communication and document corrective actions.
🎓 Qualifications Required
- Degree Eligibility:
- B.Pharm / M.Pharm / Pharm.D
- B.Sc / M.Sc in Life Sciences, Biotechnology, Microbiology, Nursing
- For Medical Writer: Science degree + strong English/AMA style skills.
- Experience Level:
- Freshers can apply (especially for PV & RA roles).
- 0–2 years experience preferred for all roles.
- CRA role prefers prior clinical research exposure but is open to fresh graduates with strong fundamentals.
- Additional Skills:
- Knowledge of clinical trial processes, PV systems, or regulatory guidelines.
- Strong communication and organizational skills.
- Proficiency in Microsoft Office & clinical trial software.
- Willingness to travel for CRA role.
💡 Why Join Syneos Health?
- Work with a global leader in CRO and clinical solutions.
- Exposure to FDA, EMA, and international clinical & regulatory projects.
- Career growth, structured training, and mentorship.
- Supportive Total Self culture that values diversity and inclusion.
📌 Application Process
Application Link for Safety & PV Coordinator
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Application Link for Regulatory Associate
Application Link for Medical Writer I
Application Link for Clinical Research Associate (CRA)
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