Safety & PV Specialist Job At Syneos Health
The Safety & PV Specialist I (QC Experience) role at Syneos Health in Serilingampalli, Telangana, is an excellent opportunity for pharmacovigilance professionals with strong case processing and quality control expertise. This Pharmacovigilance Job position supports clinical trial, post-marketing, and spontaneous safety activities while ensuring regulatory compliance, data accuracy, and patient safety across global programs. Graduates seeking Pharmacy Jobs and want to start their career with Pharmacy Careers can apply now.
Job Details
- Job Title: Safety & PV Specialist I (QC Experience)
- Location: Serilingampalli, Telangana, India
About the Company
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization with a strong global presence across 110 countries. The company partners with customers to accelerate the delivery of therapies by combining clinical development, medical affairs, and commercial expertise. Syneos Health is driven by a people-first culture, innovation, diversity, and a commitment to improving lives worldwide.
Educational Requirements for a Pharmacovigilance Job
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Bachelor’s Degree in Pharmacy
Key Responsibilities for Pharmacovigilance Job
- Enter, track, and manage ICSRs in PVG quality and safety tracking systems as per SOPs and project-specific safety plans.
- Triage ICSRs and evaluate safety data for completeness, accuracy, and regulatory reportability.
- Perform data entry, medical coding (MedDRA), narrative writing, and query follow-up.
- Support expedited safety reporting in accordance with global regulatory requirements.
- Performing quality review of ICSRs and managing duplicate case identification is essential for this Pharmacovigilance Job.
- Conduct literature screening and safety review activities.
- Validate and submit xEVMPD product records, including MedDRA-coded indications.
- Support SPOR / IDMP-related activities.
- Ensure submission of all relevant documents to the TMF and the Pharmacovigilance System Master File.
- Participate in audits and apply regulatory intelligence to safety reporting activities.
- Maintain compliance with SOPs, ICH GCP, GVP, and global safety regulations.
Skills Required for a Pharmacovigilance Job
- Minimum 3 years of experience in pharmacovigilance case processing with QC exposure
- Experience with Clinical Trial, Post-Marketing Surveillance (PMS), and Spontaneous cases
- Strong knowledge of safety databases and medical terminology
- Understanding of clinical trial phases II–IV and post-marketing safety requirements
- Knowledge of ICH GCP, GVP, and pharmacovigilance regulations
- Proficiency in MS Word, Excel, PowerPoint, Outlook, and shared content systems
- Strong organizational, communication, and interpersonal skills
- High attention to detail with the ability to meet tight timelines
Why This Job Role?
This Pharmacovigilance Job role offers the opportunity to work with a global pharmacovigilance leader involved in the majority of novel FDA- and EMA-approved products. You will gain exposure to complex global safety programs, continuous learning, strong career development pathways, and a supportive culture focused on diversity, innovation, and meaningful impact. Graduates seeking Pharmacy Jobs and want to start their career with Pharmacy Careers can apply now.
