Safety & PV Specialist I
Updated: August 20, 2025
Location: IND-Hyderabad (Hybrid)
Job ID: 25100800
💰 Estimated Salary: ₹5.5 – 8.5 LPA (based on industry standards in India for Safety & PV Specialist I with 1–2.5 years of PV experience)
Description
Safety & PV Specialist I
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. We combine clinical development, medical affairs, and commercial insights to address evolving healthcare market realities.
Our Clinical Development model places patients and customers at the center of everything we do. By streamlining processes, embracing innovation, and fostering collaboration, we ensure faster delivery of therapies that truly change lives.
With 29,000 employees across 110 countries, Syneos Health is driven by the belief that: Work Here Matters Everywhere.
Why Syneos Health?
Career growth through structured development and progression opportunities.
Strong focus on training, mentorship, and knowledge-sharing.
A supportive and collaborative work environment.
Total Self Culture – fostering inclusivity, authenticity, and belonging.
Recognition programs and global exposure across major regulatory markets.
Job Responsibilities
Process Individual Case Safety Reports (ICSRs), including spontaneous reports (mandatory).
Enter ICSR data into safety databases, ensuring accuracy and compliance with SOPs and regulatory requirements.
Triage ICSRs, evaluate completeness, accuracy, and reportability.
Code events, medical history, concomitant medications, and tests using MedDRA.
Write and compile complete narrative summaries.
Manage ICSR queries and ensure satisfactory resolution.
Generate and support timely expedited safety reporting.
Maintain safety tracking systems for assigned projects.
Perform literature screening, drug coding, and dictionary maintenance.
Validate and submit xEVMPD product records.
Conduct manual recoding of un-coded product and substance terms.
Identify and manage duplicate ICSRs.
Support SPOR/IDMP-related activities.
Conduct quality reviews of ICSRs and safety documents.
Ensure compliance with Trial Master File (TMF) and Pharmacovigilance System Master File requirements.
Apply safety reporting regulatory intelligence to ongoing activities.
Maintain updated knowledge of SOPs, WIs, GCP, ICH, GVP guidelines, and PV processes.
Participate in audits and foster strong professional relationships with project team members.
Qualification & Experience
Required Education:
B.Pharm / M.Pharm / BDS / BMS / MBBS
(B.Sc / M.Sc not eligible for this role)
Experience:
1–2.5 years in Pharmacovigilance (ICSR processing mandatory; spontaneous case handling required).
Core Skills:
Strong medical and pharmacological knowledge.
Excellent written and spoken English.
Proficiency with safety databases and tracking systems.
Ability to multitask, document, and maintain high accuracy.
Strong collaboration and communication skills.
Additional Information
Hybrid work arrangement based in Hyderabad (Office-based).
Role involves ICSR case processing with focus on quality, compliance, and regulatory timelines.
Candidates must demonstrate strong medical knowledge and comfort with global PV requirements.
Summary
The Safety & PV Specialist I role is ideal for professionals with 1–2.5 years of PV experience seeking to advance in case processing and regulatory compliance. The position emphasizes ICSR handling (especially spontaneous reports), MedDRA coding, literature screening, xEVMPD validation, and audit readiness, while fostering growth in a global pharmacovigilance environment.
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