Syneos Health, a global leader in integrated biopharmaceutical solutions, is currently hiring for the role of Safety & Pharmacovigilance Specialist I in Gurugram and Hyderabad. This is an excellent opportunity for life sciences graduates to join a growing company that values diversity, innovation, and career development.
About Syneos Health
With a workforce of 29,000 employees spread across 110 countries, Syneos Health is dedicated to accelerating customer success in clinical, medical affairs, and commercial domains. The company fosters an inclusive “Total Self” culture that encourages employees to bring their authentic selves to work. Syneos Health focuses on simplifying processes, enhancing efficiency, and delivering faster therapies to make a global impact.
Key Responsibilities of the Role
- Individual Case Safety Reports (ICSR) Management: Enter, track, and triage ICSRs in pharmacovigilance systems ensuring data completeness and compliance with Standard Operating Procedures (SOPs) and safety plans.
- Data Entry & Coding: Record safety data including medical history, events, and medication codes using MedDRA and drug dictionaries.
- Narrative Preparation & Query Resolution: Summarize cases and resolve data discrepancies or missing information.
- Expedited Safety Reporting: Support timely reporting in compliance with regulatory requirements.
- Literature Screening: Monitor scientific literature for safety signals and updates.
- Database Maintenance: Maintain and validate product records in xEVMPD with appropriate coding.
- Duplicate Management & Regulatory Activities: Identify duplicate ICSRs and support regulatory data activities such as SPOR/IDMP.
- Quality Review & Compliance: Perform quality checks on ICSRs and ensure submission to Trial Master Files (TMF).
- Regulatory Adherence: Maintain compliance with GCP, ICH guidelines, GVP, and other global regulations.
- Audit Participation & Stakeholder Collaboration: Actively participate in audits and work with internal and external teams to ensure compliance and quality.
Qualifications & Skills Required
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related fields.
- 2 to 5 years of experience in pharmacovigilance or related safety roles.
- Familiarity with safety databases, medical terminology, and clinical trials (Phases II-IV).
- Strong knowledge of Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), and global regulatory requirements.
- Proficient in Microsoft Office suite (Word, Excel, PowerPoint, Outlook) and safety tracking systems.
- Excellent organizational skills with an eye for detail and ability to manage multiple tasks efficiently.
- Strong communication and interpersonal skills to work in collaborative environments.
Why Join Syneos Health?
- Career Growth: Access to training, skill development, and advancement opportunities.
- Inclusive Work Culture: Work in a supportive, diverse environment that values every employee’s unique contributions.
- Global Exposure: Collaborate with teams and projects spanning 110 countries.
- Competitive Rewards: Enjoy benefits, insurance, and recognition programs that reward your hard work.
- Impactful Work: Contribute to accelerating healthcare solutions that change lives globally.
Preparing for the Pharmacovigilance Role
To thrive in this role, focus on:
- Deepening your understanding of pharmacovigilance regulations and global compliance standards.
- Building proficiency with safety databases and medical coding systems like MedDRA.
- Enhancing data management and quality review skills.
- Developing clear and concise report writing and communication abilities.
- Cultivating teamwork and cross-functional collaboration skills.
Final Thoughts
The Safety & Pharmacovigilance Specialist I position at Syneos Health offers an exciting career path for life sciences professionals passionate about patient safety and drug monitoring. With robust training programs, global exposure, and a supportive work environment, Syneos Health empowers its employees to make a real difference in healthcare.
If you are detail-oriented, compliant with safety standards, and eager to grow your pharmacovigilance career, this role in Gurugram or Hyderabad could be your next big step.
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