Job Posting: Safety & Pharmacovigilance Specialist I
Summary: Syneos Health is seeking a dedicated and detail-oriented Safety & Pharmacovigilance Specialist I to join our growing team in Gurugram, India. In this role, you will be responsible for ensuring drug safety through individual case safety report (ICSR) processing, data coding, and regulatory compliance. If you possess a strong foundation in pharmacy or medicine, coupled with experience in pharmacovigilance or drug safety, this is an excellent opportunity to advance your career with a leading biopharmaceutical solutions organization.
About Syneos Health:
Syneos Health is a leading global biopharmaceutical solutions organization, driven by a passion to improve patient lives. We partner with companies of all sizes, across all therapeutic areas, to accelerate the delivery of therapies to patients in need. Our unique approach integrates clinical development, commercialization, and consulting expertise to provide comprehensive solutions throughout the drug development lifecycle.
Job Description:
As a Safety & Pharmacovigilance Specialist I, you will play a vital role in safeguarding patient well-being by ensuring the accurate and timely processing of adverse event reports. Your responsibilities will encompass a range of activities, from initial case triage to detailed data analysis and regulatory reporting.
Key Responsibilities:
- ICSR Case Processing: Perform comprehensive processing of Individual Case Safety Reports (ICSRs), including data entry, thorough case triage, and evaluation of case completeness to ensure accuracy and compliance.
- Safety Database Management: Enter, manage, and maintain data within Argus or Aris-G safety databases, ensuring data integrity and accessibility.
- Medical Coding: Apply MedDRA coding to accurately classify medical events, concomitant medications, and patient medical history within safety reports.
- Narrative Summarization & Query Resolution: Prepare clear and concise narrative summaries of safety cases and proactively resolve case queries with accuracy and timeliness, collaborating with relevant stakeholders as needed.
- Regulatory Reporting: Support expedited and periodic safety reporting activities, ensuring compliance with global regulations, including Good Pharmacovigilance Practices (GVP), International Council for Harmonisation (ICH), and Good Clinical Practice (GCP) guidelines.
- Literature Screening & Drug Dictionary Maintenance: Conduct literature screening to identify potential safety signals and maintain up-to-date drug dictionaries for accurate reference.
- Data Submissions & Management: Manage xEVMPD submissions, SPOR/IDMP activities, and ensure the identification and management of duplicate cases.
- Quality Control & Documentation: Implement robust quality control measures for ICSRs and maintain comprehensive documentation within the Trial Master File (TMF) in accordance with regulatory requirements.
- Regulatory Knowledge & Compliance: Stay current with evolving global pharmacovigilance regulations and Standard Operating Procedures (SOPs) to ensure ongoing compliance.
Qualifications:
To be considered for this role, candidates must possess the following qualifications:
- Education: Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), Bachelor of Dental Surgery (BDS), Bachelor of Medical Sciences (BMS), or Bachelor of Medicine and Bachelor of Surgery (MBBS) degree.
- Experience: A minimum of 2.5 to 4 years of proven experience in pharmacovigilance, drug safety, or ICSR case processing.
- Technical Skills: Hands-on experience with safety databases such as Argus or Aris-G, and proficiency in MedDRA coding.
- Core Competencies:
- Exceptional attention to detail and accuracy.
- A strong understanding of regulatory compliance requirements within the pharmacovigilance landscape.
- Excellent data handling and analytical skills.
- Demonstrated ability to work effectively within a team environment.
Why Join Syneos Health:
- Global Leader: Be part of a leading biopharmaceutical research organization, contributing to cutting-edge advancements in healthcare.
- Global Exposure: Gain valuable experience in global drug safety operations and compliance, broadening your professional horizons.
- Career Development: Access comprehensive training and mentorship programs to support your career growth and development within the organization.
- Inclusive Culture: Thrive in an inclusion-focused environment, fostered by Syneos Health’s Total Self philosophy, promoting authenticity and a sense of belonging.
- Competitive Benefits: Receive a competitive compensation and benefits package that aligns with your experience and contributions.
Job Details:
- Position: Safety & PV Specialist I
- Company: Syneos Health
- Location: Gurugram, India (Office-based / Hybrid)
- Experience Required: 2.5–4 years
- Education: B.Pharm / M.Pharm / BDS / BMS / MBBS
- Salary Range: ₹6,00,000 – ₹9,00,000 per annum (based on experience)
- Application Deadline: November 14, 2025
How to Apply:
Interested and qualified candidates are encouraged to apply.