Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a workforce of 29,000 employees across 110 countries, Syneos Health combines clinical, medical affairs, and commercial expertise to address modern market challenges.
The company fosters a Total Self culture, encouraging employees to bring their authentic selves to work while promoting diversity, inclusion, and career growth. Syneos Health is committed to simplifying processes, improving efficiency, and delivering therapies faster to change lives.
Job Description: Safety & Pharmacovigilance Specialist I
Key Responsibilities:
- Enter and track Individual Case Safety Reports (ICSRs) in Pharmacovigilance (PV) systems.
- Assist in processing ICSRs in compliance with SOPs and safety plans.
- Triage ICSRs, ensuring data completeness, accuracy, and regulatory compliance.
- Perform data entry into safety databases, including coding events, medications, and medical history.
- Prepare narrative summaries and resolve queries for missing information.
- Support expedited safety reporting as per regulatory requirements.
- Conduct literature screening, MedDRA coding, and drug dictionary maintenance.
- Validate and submit xEVMPD product records with appropriate MedDRA coding.
- Identify and manage duplicate ICSRs and support SPOR/IDMP activities.
- Perform quality reviews of ICSRs and ensure proper Trial Master File (TMF) submissions.
- Maintain compliance with GCP, ICH guidelines, GVP, and global regulatory requirements.
- Participate in audits and collaborate with internal/external stakeholders.
Qualifications & Skills:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.
- Experience with safety databases and medical terminology.
- Knowledge of clinical trials (Phases II-IV), post-marketing safety, GCP, GVP, and pharmacovigilance regulations.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and safety tracking systems.
- Strong organizational, communication, and interpersonal skills.
- Detail-oriented with the ability to manage multiple tasks under deadlines.
Why Join Syneos Health?
- Career growth with training and development programs.
- Inclusive and supportive work environment.
- Global exposure with a diverse team across 110 countries.
- Competitive rewards and recognition programs.
How to Apply?
Advertisement
