Syneos Health Hiring Safety & PV Specialist | Pharma Graduates | Apply
Are you looking for a Pharmacovigilance Job with a global clinical research and life sciences organization? Syneos Health is hiring a Safety & PV Specialist I for its Gurugram office. This opportunity is ideal for experienced pharmacovigilance professionals seeking to strengthen their expertise in ICSR processing, safety reporting, regulatory compliance, and drug safety operations while building a successful Syneos Career.
- Job Title: Safety & PV Specialist I
- Job Location: Gurugram, Haryana, India
About the Company
Syneos Health is a leading integrated biopharmaceutical solutions organization that supports customers across the drug development and commercialization lifecycle. The company partners with pharmaceutical, biotechnology, and healthcare innovators to accelerate the delivery of new therapies to patients worldwide.
Professionals pursuing a Syneos Career gain exposure to global clinical research, pharmacovigilance operations, regulatory compliance, and advanced drug safety systems while working alongside experienced healthcare and life sciences experts.
Job Description
This Pharmacovigilance Job involves supporting drug safety and pharmacovigilance activities through accurate processing, evaluation, coding, review, and reporting of Individual Case Safety Reports (ICSRs). The Safety & PV Specialist I will contribute to regulatory compliance, safety database management, literature screening, MedDRA coding, and safety reporting activities while ensuring adherence to global pharmacovigilance requirements and company procedures.
Key Responsibilities
- Process, review, and track ICSRs in accordance with SOPs and regulatory requirements.
- Assess safety cases for completeness, accuracy, and reportability.
- Enter and maintain pharmacovigilance data in safety databases.
- Perform MedDRA coding for adverse events, medical history, and medications.
- Prepare case narratives and follow up on missing safety information.
- Support expedited safety reporting and literature screening activities.
- Conduct quality review of ICSRs and safety documentation.
- Manage duplicate case reconciliation and pharmacovigilance data integrity.
- Support xEVMPD, SPOR, and IDMP-related activities.
- Ensure compliance with GVP, ICH, GCP, SOPs, and global safety regulations.
- Participate in audits and inspection readiness activities.
Eligibility Criteria
- Education: B. Pharm, M. Pharm
- Experience: Minimum 2.6 years of pharmacovigilance experience
Required Skills
- Strong knowledge of pharmacovigilance processes and drug safety regulations.
- Experience in ICSR processing, case triage, and safety database management.
- Understanding of MedDRA coding and adverse event reporting.
- Knowledge of GVP, ICH, GCP, and regulatory compliance requirements.
- Experience in literature screening and safety data review.
- Strong analytical, communication, and problem-solving skills.
- Ability to manage multiple safety cases while maintaining data accuracy.
This Pharmacovigilance Job at Syneos Health offers an excellent opportunity for experienced drug safety professionals looking to advance their careers in global pharmacovigilance. The role provides valuable exposure to ICSR management, safety reporting, regulatory compliance, and pharmacovigilance operations. Candidates seeking long-term growth through a Syneos Career can benefit from working in a dynamic environment focused on patient safety and healthcare innovation.
