Syneos Health Hiring Now! B.Pharm & M.Pharm Candidates Can Apply
Looking for a pharmacovigilance job in Hyderabad? Syneos Health is hiring a Safety & PV Coordinator for its office-based team. This opportunity is ideal for B.Pharm and M.Pharm candidates with at least 1 year of experience in PMS and spontaneous cases. Explore Syneos Health careers and build your career in pharmacovigilance.
Job Details
- Job Title: Safety & PV Coordinator (Hyderabad Office-based)
- Job Requisition ID: 25110587
- Location: Hyderabad, India
About the Company
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. The company partners with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. Syneos Health is committed to building an inclusive culture where employees can authentically be themselves, fostering collaboration and innovation to shape the future of healthcare.
Key Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs as required. Assists in processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
- Maintains safety tracking for assigned activities.
- Performs literature screening and review for safety, drug coding, and maintenance of the drug dictionary, including MedDRA coding as required.
- Validation and submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
- Manual recoding of un-recoded product and substance terms arising from ICSRs.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
- Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process.
- Fosters constructive and professional working relationships with all project team members, both internal and external.
- Participates in audits as required/appropriate.
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Eligibility Criteria
- Education: B.Pharm/M.Pharm only
- Experience: Minimum 1 year of experience in PMS and spontaneous cases
- Preferred Database: LSMV, fine to proceed with Argus
- Safety Database systems and knowledge of medical terminology are required.
- Good understanding of clinical trial processes across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP, and regulations related to Safety and Pharmacovigilance.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, email (Outlook), Teams, and the internet.
- Ability to work independently and in a team environment.
- Excellent communication and interpersonal skills, both written and spoken.
- Good organizational skills with a proven ability to prioritize and work on multiple tasks and projects.
- Detail-oriented with a high degree of accuracy and the ability to meet deadlines.
Why Join Syneos Health?
Discover what your 25,000 future colleagues already know: Syneos Health is passionate about developing its people through career development and progression, supportive management, and a total rewards program. The organization is continuously building a culture that fosters innovation and collaboration, allowing employees to challenge the status quo and drive impact for customers while shaping the future of healthcare.
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