Pharmacovigilance Job at Syneos Health
A rare chance has emerged for professionals in pharmacovigilance as Syneos Health seeks a Safety & PV Specialist II for Literature Case Processing in Gurugram. This is a full-time position. The Pharmacovigilance Job offers an opportunity to contribute to drug safety and compliance in a leading life sciences organisation.
About Syneos Health:
Syneos Health® is a leading, fully integrated life sciences services organisation built to accelerate customer success. They partner with innovators at every point across the drug development and commercialisation continuum, helping them navigate complexity, anticipate change, and accelerate progress. Their Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions they shape.
Job Details:
- Job Title: Safety & PV Specialist II – Literature Case Processing
- Location: Gurugram, India
- Job Requisition ID: 25113146
- Job Type: Full-time
Job Description:
The Safety & PV Specialist II will be responsible for entering information into pharmacovigilance quality and tracking systems, processing literature-derived Individual Case Safety Reports (ICSRs), and conducting comprehensive literature screening to identify and process potential adverse events. The role requires maintaining safety tracking systems, ensuring compliance with project and regulatory requirements, and fostering effective working relationships with stakeholders.
Key Responsibilities:
- Enter information into PV quality and tracking systems for receipt and tracking of ICSRs.
- Perform comprehensive literature screening, review, and Medical Literature Monitoring (MLM) activities.
- Maintain safety tracking systems and ensure timely completion of assigned activities.
- Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.
- Perform quality review of ICSRs ensuring compliance with project and regulatory requirements.
- Identify, reconcile, and manage duplicate safety cases.
- Support validation and submission activities related to xEVMPD, SPOR, and IDMP requirements.
- Assist with manual recoding of products, substances, and indication terms when required.
Eligibility Criteria for the Pharmacovigilance Job:
- 4-7 years of Pharmacovigilance experience, including significant experience in Literature Case Processing and Medical Literature Monitoring (MLM).
- PharmD, BDS, or equivalent healthcare-related qualification.
- Strong hands-on experience in ICSR processing, literature surveillance, data entry, narrative writing, and case management.
- Good understanding of clinical trials, post-marketing safety requirements, ICH-GCP, GVP, and pharmacovigilance regulations.
- Experience in quality review activities and regulatory compliance processes.
- Proficiency in Microsoft Office Suite and other collaborative platforms.
- Excellent written and verbal communication skills.
- Detail-oriented with a high degree of accuracy and commitment to quality and compliance.
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