Job Title:
Safety & PV Specialist I
π Location: IND – Gurugram (Hybrid)
π Job ID: 25100771
π
Updated: August 20, 2025
π’ Company: Syneos Health
π Company Overview
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our mission is to put the patient and customer at the center of everything we do by delivering innovative clinical, medical affairs, and commercial solutions.
“Work Here Matters Everywhere” — Join a global network of 29,000 employees across 110 countries working to improve health outcomes worldwide.
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π Position Summary
As a Safety & PV Specialist I, you will play a key role in supporting pharmacovigilance (PV) activities, ensuring accurate and timely processing, tracking, and reporting of Individual Case Safety Reports (ICSRs). You will work closely with cross-functional teams to maintain compliance with regulatory requirements and company standards.
π― Key Responsibilities
π Case Processing & Data Entry
Enter and track ICSRs in PVG quality and tracking systems.
Assist in processing ICSRs in line with SOPs and project-specific safety plans.
Triage ICSRs, evaluate completeness, accuracy, and reportability.
Enter data and code events, medical history, concomitant medications, and tests in safety databases.
Compile comprehensive narrative summaries.
Identify and resolve data queries promptly.
π Safety Reporting & Compliance
Assist in generating timely and accurate expedited safety reports according to regulatory requirements.
Maintain safety tracking for assigned activities.
Conduct literature screening and review for safety signals.
Perform drug coding and maintain drug dictionaries using MedDRA.
Validate and submit xEVMPD product records; recode un-recoded product/substance terms.
Manage duplicate ICSRs and activities related to SPOR/IDMP.
Conduct quality review of ICSRs.
Ensure submission of all relevant documents to Trial Master File (TMF) and Pharmacovigilance System Master File as per SOPs and sponsor requirements.
π Regulatory & Process Adherence
Maintain compliance with SOPs, Work Instructions, global regulations (GCP, ICH, GVP), and project plans.
Apply safety reporting regulatory intelligence to all safety activities.
Foster professional relationships with internal and external project team members.
Participate in audits as required.
π§Ύ Qualifications & Skills
Strong attention to detail and ability to maintain high-quality data entry and case processing.
Familiarity with pharmacovigilance systems and regulatory requirements.
Ability to work collaboratively and maintain professional communication.
Proactive and able to handle multiple tasks within deadlines.
Commitment to maintaining compliance with applicable regulations and company policies.
π Why Join Syneos Health
Supportive and engaging environment with career development and training opportunities.
Inclusive Total Self culture that encourages authenticity and diversity.
Opportunity to contribute to impactful projects improving patient lives.
Hybrid work model for work-life balance.
π Additional Information
Duties and responsibilities are not exhaustive and may change at the company’s discretion.
Equivalent skills, experience, or education may be considered.
The company complies with all applicable employment laws, including the EU Equality Directive and the Americans with Disabilities Act.
This job description is not a contract of employment.
π How to Apply
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