Life Science Job at Syneos Health | Safety & PV Specialist | Apply Now
Syneos Health, a global leader in integrated biopharmaceutical solutions, is hiring a Safety & PV Specialist I for its operations in Serilingampalli, Hyderabad. This life science job is specifically designed for professionals with a strong background in Pharmacovigilance (PV) and Quality Control (QC), offering a high-impact Syneos Health career within a Functional Service Provider or Full-Service environment. Working at Syneos Health means joining an organization that has contributed to 94% of all novel FDA-approved drugs over the past five years.
- Job Position: Safety & PV Specialist l (QC Experience)
- Location: Serilingampalli, Telangana, India
About the Company
Syneos Health is a “fully integrated” biopharmaceutical solutions organization. Unlike traditional CROs, it combines Clinical Development and Commercialization insights to accelerate patient access to therapies. By putting the patient at the center of their model, they streamline the drug development process in a highly competitive global market.
Job Overview
This role is an entry-to-developing individual contributor position within the Pharmacovigilance & Safety job family. You will be responsible for the end-to-end processing of Individual Case Safety Reports (ICSRs), ensuring data integrity, regulatory compliance, and clinical safety.
Key Responsibilities:
- ICSR Processing: Triage, evaluate, and enter data for ICSRs into safety databases, ensuring completeness and accuracy.
- Quality Control (QC): Perform rigorous quality reviews of ICSRs to maintain high data standards.
- Coding & Narratives: Apply MedDRA and drug dictionary coding for events, medical history, and medications, and compile comprehensive narrative summaries.
- Regulatory Compliance: Identify reportable expedited cases and assist in timely reporting to global regulatory authorities.
- System Maintenance: Validate and submit xEVMPD product records and support activities related to SPOR/IDMP.
- Documentation: Ensure all safety documents are accurately submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File.
Qualifications & Skills Required
To qualify for this pharmacovigilance job, candidates must meet the following criteria:
- Education: Bachelor’s Degree in Life Science.
- Experience: Minimum of 3 years of experience in Case Processing, which must include specific QC experience.
- Clinical Knowledge: Prior experience with Clinical Trials, Post-Marketing Surveillance (PMS), and Spontaneous cases.
- Regulatory Expertise: Solid understanding of ICH GCP, GVP, and clinical trial processes across Phases II-IV.
- Technical Skills: Proficiency in Safety Database systems, MedDRA coding, and Microsoft Office Suite.
Why Pursue a Syneos Health Career?
- Total Self Culture: An environment that celebrates diversity of thought and encourages employees to be their authentic selves.
- Professional Development: Access to technical training, therapeutic area expertise, and a structured career progression path.
- Global Impact: Join a team of 29,000 employees across 110 countries working on therapies that change lives.
- Comprehensive Rewards: Competitive total rewards program and peer recognition initiatives.
Securing a pharmacovigilance job at Syneos Health’s Hyderabad hub is a strategic career move for professionals dedicated to drug safety and data integrity. This life science job offers a unique opportunity to apply specialized QC experience within a globally integrated biopharmaceutical model that has supported the vast majority of recent FDA and EMA approvals. By pursuing a Syneos Health career, you will be at the forefront of protecting patient safety through rigorous ICSR processing and regulatory compliance in a “Total Self” culture that values diversity and professional growth. If you have the required three years of case processing expertise and a passion for clinical excellence, this role provides the ideal platform to make an impact that matters everywhere.
