Job Title: Safety & Pharmacovigilance Specialist I
Location: Hyderabad, India (Asia Pacific)
Category: Pharmacovigilance / Drug Safety
Company: Syneos Health
Job ID: 25001642
Job Description:
As a Safety & Pharmacovigilance (PV) Specialist I at Syneos Health, you’ll play an essential role in ensuring drug safety and regulatory compliance during clinical trials and post-marketing activities. Working in a collaborative and dynamic global environment, your responsibilities will support patient safety and enhance data integrity across global biopharmaceutical studies.
Why Syneos Health?
Global organization with 29,000 employees in 110 countries
Passionate focus on career growth, learning, and progression
Inclusive Total Self culture that supports authenticity and diversity
Leading provider for 94% of all FDA novel drug approvals over the last 5 years
Work that matters everywhere – with impact across healthcare innovation
Key Responsibilities:
Enter and manage data in Pharmacovigilance (PVG) tracking systems
Process and triage Individual Case Safety Reports (ICSRs)
Code medical terms (e.g., events, history, medications) and compile narratives
Query and follow up on incomplete or unclear safety data
Ensure accurate and timely regulatory submissions
Perform literature screening, MedDRA coding, and xEVMPD submissions
Identify and manage duplicate ICSRs
Quality review of case reports and proper documentation in TMF
Maintain compliance with SOPs, GCP, GVP, ICH, and regulatory requirements
Collaborate with internal and external project team members
Participate in audits and apply global safety regulatory intelligence
Qualifications:
Bachelor’s Degree in life sciences, nursing, pharmacy, or equivalent field
Familiarity with safety databases and medical terminology
Understanding of clinical trial phases (II–IV) and post-marketing safety processes
Proficiency in Microsoft Office Suite, Visio, Outlook, and content management tools
Strong communication, organizational, and time-management skills
Ability to multitask and work both independently and collaboratively
High attention to detail and ability to meet deadlines
Additional Information:
This job description is not exhaustive; other duties may be assigned as required
Equivalent education or experience may be considered
Syneos Health is an equal opportunity employer, committed to compliance with local and international employment laws
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