Job Title: Safety & Pharmacovigilance (PV) Specialist I – QC Experienced
Location: Pune, India
Job Type: Full-Time, Regular
Job ID: 25104167
Category: Pharmacovigilance | Drug Safety | Clinical Development
Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, delivering innovative clinical, medical, and commercial solutions that accelerate the development of therapies worldwide. With a presence across 110 countries and over 29,000 employees, we bring together diverse expertise to support clinical trials, post-marketing safety, and regulatory compliance, ensuring better outcomes for patients globally.
Role Overview:
We are seeking a Safety & PV Specialist I with hands-on Quality Control (QC) experience to join our Pharmacovigilance team in Pune. The ideal candidate will have a strong background in ICSR processing, QC review, and regulatory compliance across clinical trials (Phases II–IV) and post-marketing surveillance. This role provides an opportunity to contribute to global drug safety, support regulatory reporting, and enhance pharmacovigilance processes.
Key Responsibilities:
1. Case Processing & Quality Control:
Enter, triage, and track Individual Case Safety Reports (ICSRs) in PVG quality and tracking systems.
Perform data verification for completeness, accuracy, and regulatory reportability.
Code adverse events, medical history, concomitant medications, and laboratory results using MedDRA.
Prepare detailed narrative summaries and follow up on queries to ensure completeness of safety data.
Identify and manage duplicate ICSRs and perform manual recoding when necessary.
2. Regulatory & Safety Reporting Support:
Assist in generating timely and accurate expedited safety reports in compliance with global regulatory requirements.
Maintain safety tracking for assigned activities and ensure proper submission to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Support validation and submission of xEVMPD product records, coding indication terms per MedDRA standards.
Stay updated on GCP, ICH, and GVP guidelines and regulatory intelligence for safety reporting.
3. Literature Screening & Data Management:
Conduct literature review for safety signal detection and drug coding updates.
Maintain and update drug dictionaries and ensure accuracy in safety databases.
Support activities related to SPOR / IDMP compliance and regulatory standards.
4. Collaboration & Audits:
Work constructively with internal teams, external stakeholders, and cross-functional project members.
Participate in audits and inspections as required.
Contribute to process improvement initiatives in pharmacovigilance and case management.
Required Qualifications & Experience:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or equivalent.
Minimum 3 years of experience in ICSR processing and QC within pharmacovigilance.
Experience handling clinical trial (Phases II–IV), post-marketing, and spontaneous safety cases.
Strong understanding of safety database systems, medical terminology, and PV processes.
Knowledge of ICH GCP, GVP, and global safety regulations.
Proficiency in Microsoft Office Suite, email, shared content/workspace platforms, and internet research.
Detail-oriented, excellent organizational skills, and ability to manage multiple tasks.
Strong written and verbal communication skills; able to work independently and in a team environment.
Preferred Skills:
Familiarity with MedDRA coding, SPOR / IDMP standards, and pharmacovigilance quality review processes.
Experience supporting regulatory submissions and safety reporting audits.
Why Join Syneos Health:
Contribute to global pharmacovigilance operations supporting novel FDA-approved and EMA-authorized products.
Collaborate with passionate professionals in a diverse, inclusive, and high-impact environment.
Opportunities for career progression, therapeutic area training, and professional development.
Engage in a culture that values authenticity, innovation, and continuous improvement.
Compensation & Benefits:
Competitive salary and benefits package commensurate with experience, including health coverage, paid leave, training opportunities, and professional development programs.
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