Safety &

- PV Specialist I - Medical Device &
- PQC Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

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Job Responsibilities ob Responsibilities Job Title: Safety &





- Pharmacovigilance Specialist I Location: Hyderabad, India (Office-Based) Employment Type: Full-Time Experience Required: 2.5 4 Years Job Summary The Safety &
- Pharmacovigilance Specialist I is responsible for end-to-end ICSR processing, safety data management, regulatory reporting support, and compliance with global pharmacovigilance regulations. The role requires demonstrated expertise in Product Quality Complaint (PQC) case handling and experience in medical research safety cases.

Key Responsibilities ICSR Processing &

- Case Management Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs. Process ICSRs in accordance with Standard Operating Procedures (SOPs) and project/program-specific safety plans. Triage ICSRs and evaluate case data for completeness, accuracy, and regulatory reportability. Enter case data into the safety database (Argus / ARISg). Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and relevant dictionaries. Prepare comprehensive and medically accurate narrative summaries. Identify missing or inconsistent information and follow up on queries until satisfactory resolution. Identify and manage duplicate ICSRs. Perform quality review of ICSRs.

Regulatory

Reporting &

- Compliance Assist in the preparation and submission of timely, consistent, and accurate expedited safety reports in accordance with global regulatory requirements.



Validate and submit xEVMPD product records, including appropriate MedDRA coding of indication terms. Perform manual recoding of un-coded product and substance terms arising from ICSRs. Support SPOR / IDMP-related activities. Maintain safety tracking for assigned activities. Ensure all relevant documents are submitted to the Trial Master File (TMF) for clinical trials and the Pharmacovigilance System Master File (PSMF) for post-marketing programs, as applicable. Apply safety reporting regulatory intelligence to all safety reporting activities. Literature, Audit &
- Collaboration Perform literature screening and safety review. Maintain drug dictionaries and support coding activities. Maintain compliance with SOPs, Work Instructions (WIs), GCP, ICH guidelines, GVP, and global drug/biologic/device regulations. Participate in audits and support inspection readiness. Foster constructive and professional working relationships with internal and external stakeholders.

Required Qualifications Education: B.Pharm / M.Pharm / PharmD / BDS / BMS / MBBS (B.Sc / M.Sc not eligible) Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively.

Experience in handling medical research-related safety cases. Hands-on experience in Argus / ARISg safety database. Strong understanding of global pharmacovigilance regulations and reporting requirements.

Knowledge of clinical trial phases IIIV and/or post-marketing safety. Proficiency in Microsoft Office applications Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your .

📌 Safety & PV Specialist I - Medical Device & PQC (India)
🏢 5264 Syneos Health India Private
📍 India