Syneos Health Hiring for PV Role | Pharmacy Graduates Apply Now
A Syneos Health Pharmacovigilance Job opportunity has emerged for professionals in pharmacovigilance and safety, as Syneos Health seeks a Safety & PV Specialist I for Literature Case Processing. This role offers an opportunity to contribute to the drug development process while working alongside a dedicated team. Interested candidates are encouraged to apply soon.
About The Company
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. The company partners with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. Syneos Health is committed to building an inclusive culture where employees can authentically be themselves, driven by the purpose of delivering impactful healthcare solutions.
- Position: Safety & PV Specialist I – Literature Case Processing
- Location: Gurgaon
Syneos Health Pharmacovigilance Job Description
The Safety & PV Specialist I will be responsible for entering information into quality and tracking systems for the receipt and tracking of Individual Case Safety Reports (ICSRs). The role requires assistance in processing ICSRs according to Standard Operating Procedures (SOPs), triaging ICSRs, and ensuring compliance with regulatory requirements. In this Syneos Health Pharmacovigilance Job, the specialist will also perform literature screening and review, maintain safety tracking, and manage duplicate ICSRs.
Key Responsibilities
- In this Syneos Health Pharmacovigilance Job, the candidates will enter information into PVG quality and tracking systems for receipt and tracking of ICSRs as required.
- Assist in the processing of ICSRs according to SOPs and project-specific safety plans.
- Perform literature screening and review for safety, drug coding, and maintenance of the drug dictionary.
- Validation and submission of xEVMPD product records, including appropriate coding of indication terms.
- Identification and management of duplicate ICSRs.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOPs.
- Participate in audits as required.
- Foster professional working relationships with all project team members.
Eligibility for the Safety & PV Specialist I Role
- Ideal candidate should have 2+ years of experience in Literature Data entry along with MLM experience.
- Should have M.Pharma / Pharm D Degree or Equivalent.
- Knowledge of safety database systems and medical terminology is required.
- Good understanding of clinical trial processes across Phases II-IV and post-marketing safety requirements.
- Proficiency in Microsoft Office Suite and other relevant software.
- Excellent communication and interpersonal skills, both written and spoken.
- Detail-oriented with a high degree of accuracy and ability to meet deadlines.
Documents Required
- Resume/CV
- Cover letter
- Relevant certifications
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks and responsibilities at its discretion. Equivalent experience, skills, and/or education will also be considered, and the Company will determine what constitutes equivalent qualifications.
Why Join Syneos Health
Syneos Health has worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. The organization is committed to building a workplace where smart colleagues from around the world collaborate to shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Qualified candidates are encouraged to consider this Syneos Health Pharmacovigilance Job and apply before the deadline. This role not only promises professional growth but also the chance to make a significant impact in the field of pharmacovigilance and safety.
