Safety & PV Specialist I Pharmacovigilance in Gurugram | Syneos Health

Safety & PV Specialist I Pharmacovigilance Jobs in Gurugram | Syneos Health Careers Company: Syneos Health

Job Title: Safety & PV Specialist I

Location: Gurugram, India

Job Type: Full-Time

Industry: Pharmacovigilance, Drug Safety, Clinical Research

Job ID: hidden_mobile2

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About Syneos Health Syneos Health is a leading global biopharmaceutical solutions organization that supports pharmaceutical, biotechnology, and healthcare companies across clinical development and commercialization. The company partners with life sciences innovators to accelerate drug development, improve regulatory outcomes, and support patient safety worldwide.

With a strong presence in clinical research, pharmacovigilance, medical affairs, and regulatory services, Syneos Health offers professionals an opportunity to work on global healthcare and drug safety projects.

Job Overview Syneos Health is hiring a Safety & PV Specialist I for its Pharmacovigilance and Drug Safety team in Gurugram, India.

The role focuses on:

ICSR Case Processing Adverse Event Management Safety Database Operations MedDRA Coding Post-Marketing Pharmacovigilance Regulatory Safety Reporting This opportunity is ideal for professionals with prior experience in pharmacovigilance and clinical safety operations looking to build a long-term career in global drug safety and regulatory compliance.

Experience Required Required Experience Minimum 2 to 4 years of experience in: ICSR Case Processing Pharmacovigilance Operations Drug Safety Mandatory Experience Candidates must have experience handling:

Post-Marketing Case Processing Spontaneous Cases Clinical Trial Safety Cases Literature Cases Freshers Eligibility Freshers are not eligible Prior pharmacovigilance experience is mandatory Source:

Educational Qualification Applicants should possess:

Bachelors Degree in: Life Sciences Pharmacy Nursing Healthcare-related field OR

Equivalent relevant experience in Pharmacovigilance or Drug Safety Operations Key Responsibilities ICSR Processing Process Individual Case Safety Reports (ICSRs) Perform case intake, triage, and safety data review Validate case completeness and regulatory reportability Enter and maintain data in safety databases Drug Safety & Coding Activities Perform: MedDRA Coding Drug Dictionary Maintenance Medical History Coding Concomitant Medication Coding Narrative Writing & Query Resolution Prepare detailed case narratives Follow up on missing or incomplete information Resolve safety queries within timelines Regulatory Safety Reporting Support expedited reporting activities Ensure compliance with: ICH-GCP GVP Global Pharmacovigilance Regulations Advanced Pharmacovigilance Activities xEVMPD Product Record Validation & Submission SPOR / IDMP activities Duplicate ICSR Management Quality review of safety cases Documentation & Compliance Maintain Trial Master File (TMF) documentation Participate in audits and quality reviews Follow SOPs, WIs, and safety reporting standards .