Pharmacovigilance Safety PV Specialist I Job in Hyderabad at Syneos Health for ICSR processing and global drug safety operations.
About the Company
Syneos Health is a leading global biopharmaceutical solutions organization that integrates clinical development, medical affairs, and commercial capabilities. Over the past five years, Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, working across more than 200 studies, 73,000 sites, and 675,000+ clinical trial patients worldwide. Pharmacovigilance Safety PV Specialist I Job
The organization is known for its strong pharmacovigilance systems, regulatory expertise, and structured career growth opportunities in drug safety and clinical research domains. Pharmacovigilance Safety PV Specialist I Job
Job Details
- Company: Syneos Health
- Job Title: Safety & Pharmacovigilance Specialist I
- Job ID: 25001642
- Job Location: Hyderabad, India
- Employment Type: Full-Time
- Industry: Pharmacovigilance / Drug Safety
- Experience Level: Entry to Mid-level
Job Description
Syneos Health is hiring Pharmacovigilance Safety & PV Specialist I professionals to support global drug safety operations based in Hyderabad. This role is focused on Individual Case Safety Report (ICSR) processing, safety database management, regulatory compliance, and pharmacovigilance documentation across clinical trial and post-marketing programs. Pharmacovigilance Safety PV Specialist I Job
The position provides exposure to global pharmacovigilance systems, regulatory reporting standards, and end-to-end safety case management in a highly regulated environment. Pharmacovigilance Safety PV Specialist I Job
Job Role & Responsibilities
The Safety & Pharmacovigilance Specialist I will support pharmacovigilance activities in accordance with global regulations, company SOPs, and project-specific safety plans. Pharmacovigilance Safety PV Specialist I Job
Key Responsibilities
- Enter and track ICSR information in pharmacovigilance quality and tracking systems
- Process ICSRs in compliance with SOPs and project/program-specific safety plans
- Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability
- Perform data entry into safety databases
- Code adverse events, medical history, concomitant medications, and tests
- Compile complete and accurate safety narratives
- Identify missing information, generate queries, and follow up until resolution
- Support preparation and submission of expedited safety reports as per regulatory timelines
- Maintain safety tracking logs for assigned activities
- Perform literature screening and safety review activities
- Support drug coding, MedDRA coding, and maintenance of drug dictionaries
- Validate and submit xEVMPD product records, including MedDRA-coded indications
- Perform manual recoding of un-recoded product and substance terms from ICSRs
- Identify and manage duplicate ICSRs
- Support SPOR / IDMP-related pharmacovigilance activities
- Conduct quality review of ICSRs
- Ensure submission of safety documents to TMF and Pharmacovigilance System Master File
- Maintain compliance with SOPs, WIs, GCP, ICH guidelines, GVP, and global safety regulations
- Participate in audits and inspections as required
- Collaborate professionally with internal and external project stakeholders
Pharmacovigilance Safety PV Specialist I Job
Eligibility / Qualifications
Required Education
- Bachelor’s degree in Life Sciences
- OR Registered Nurse
- OR Pharmacist
- OR equivalent combination of education and relevant experience
Experience Requirement
- Experience in ICSR case processing activities
- Hands-on exposure to safety database systems
- Working knowledge of medical terminology
Preferred Skills
- Understanding of clinical trial processes (Phase II–IV) and post-marketing safety
- Knowledge of ICH-GCP, GVP, and global pharmacovigilance regulations
- Experience with MedDRA coding and safety data review
- Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and collaboration tools
- Strong attention to detail and high accuracy
- Ability to manage multiple tasks and meet deadlines
- Good communication and interpersonal skills
- Ability to work independently and in team-based environments
Pharmacovigilance Safety PV Specialist I Job
Location & Salary
- Job Location: Hyderabad, India
- Employment Type: Full-Time
- Annual Salary Range: ₹3,50,000 – ₹5,00,000 (as per company standards and experience)
Why You Should Join
- Work with a globally recognized pharmacovigilance leader
- Exposure to international drug safety regulations and systems
- Structured learning and career growth in pharmacovigilance
- Opportunity to support global clinical trials and post-marketing programs
- Collaborative and compliance-driven work culture
Pharmacovigilance Safety PV Specialist I Job
Frequently Asked Questions (FAQs)
Who can apply for this role?
Life science graduates, pharmacists, registered nurses, or candidates with equivalent experience in pharmacovigilance can apply.
Is this a full-time position?
Yes, this is a full-time role based in Hyderabad.
Is experience mandatory?
Prior experience in ICSR processing and safety databases is required or preferred.
What type of pharmacovigilance work is involved?
The role focuses on ICSR processing, safety database activities, regulatory reporting, coding, and quality review.
Does the role involve global regulatory exposure?
Yes, the role involves compliance with global regulations including ICH, GVP, and international safety standards.
Job Summary Table
| Details | Information |
|---|---|
| Company | Syneos Health |
| Position | Safety & Pharmacovigilance Specialist I |
| Job ID | 25001642 |
| Employment Type | Full-Time |
| Location | Hyderabad |
| Salary Range | ₹3.5 – ₹5 LPA |
| Industry | Pharmacovigilance / Drug Safety |
How to Apply
Interested candidates can apply through the official Syneos Health careers portal using the Apply Here option provided in the job listing.
Ensure your resume highlights ICSR processing experience, safety database exposure, and pharmacovigilance regulatory knowledge for better shortlisting.
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