Safety & PV Specialist I
Location: Hyderabad / Gurgaon, India (Hybrid)
Job Type: Full-Time
Job ID: 25100800
Updated: Today
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. With 29,000 employees across 110 countries, Syneos Health partners with global pharma and biotech leaders to deliver innovative clinical development, medical affairs, and commercial solutions.
Over the past 5 years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000 sites and 675,000+ trial patients
At Syneos Health, Work Here Matters Everywhere – we bring patients, customers, and employees to the center of everything we do.
Job Summary
The Safety & PV Specialist I will be responsible for processing and evaluating Individual Case Safety Reports (ICSRs) and performing pharmacovigilance activities in compliance with regulatory requirements, SOPs, and project-specific safety plans. This role supports global PV operations with a focus on ICSR case processing, spontaneous reporting, MedDRA coding, and literature review.
Key Responsibilities
Pharmacovigilance Operations
Perform ICSR case processing (spontaneous cases mandatory).
Triaging, evaluating completeness, accuracy, and regulatory reportability of ICSRs.
Enter case data into the safety database.
Code events, medical history, concomitant medications, and test results.
Compile narrative summaries for case reports.
Identify missing information, generate queries, and follow-up to resolution.
Generate expedited safety reports in compliance with global regulations.
Manage safety tracking activities for assigned projects.
Conduct literature screening/review for safety signals and drug coding.
Data & Regulatory Compliance
Perform MedDRA coding for events, indications, and drug terms.
Validate and submit xEVMPD product records.
Support SPOR/IDMP-related activities.
Identify and resolve duplicate cases in safety database.
Ensure submission of required documents to Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain compliance with SOPs, Work Instructions (WIs), GVP, ICH, GCP, and regulatory guidelines.
Quality & Collaboration
Perform quality review of ICSRs.
Ensure accuracy and timeliness of PV deliverables.
Foster constructive, professional working relationships with internal and external stakeholders.
Participate in audits and inspections as required.
Apply regulatory intelligence to safety reporting activities.
Qualifications
Education
B.Pharm / M.Pharm / BDS / BMS / MBBS (❌ BSc/MSc not eligible).
Experience
1 – 2.5 years of experience in Pharmacovigilance.
Prior experience in ICSR case processing with spontaneous reporting required.
Skills & Competencies
Strong English communication skills (written & verbal).
Good knowledge of medical terminology.
Familiarity with safety databases and global regulatory guidelines.
Strong attention to detail and ability to work within timelines.
Salary Range
₹5,50,000 – ₹8,00,000 per annum (estimated, based on PV Specialist I roles in Hyderabad/Gurgaon CRO & pharma sector).
Why Join Syneos Health
Work on global drug safety projects with top pharma companies.
Career development and progression opportunities.
Training in therapeutic areas and PV operations.
Inclusive Total Self culture – where diversity and authenticity are valued.
Competitive rewards and recognition programs.
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