Pharmacy Job at Syneos Health | Apply for the Safety & PV Specialist Role
Syneos Health is hiring a Safety & PV Specialist I for its on-site operations in Gurgaon and Hyderabad, India. This Pharmacy Job is ideal for life science professionals with a minimum of 2.5 years of experience in Pharmacovigilance, specifically in ICSR case processing and Argus database management. You will be responsible for triaging safety reports, performing MedDRA coding, and ensuring global regulatory compliance for both clinical trials and post-marketing programs.
- Job Title: Safety & PV Specialist I (Gurgaon / Hyderabad Location)
- Location: Gurgaon, Haryana, India
About The Company
Syneos Health® is a leading global biopharmaceutical solutions organization designed to accelerate customer success by integrating clinical development, medical affairs, and commercial insights. With approximately 29,000 employees across 110 countries, the firm has contributed to the development or commercialization of 94% of all novel FDA-approved drugs and 95% of EMA-authorized products over the last five years. Syneos Health operates a uniquely integrated model, combining the capabilities of a Contract Research Organization (CRO) and a Contract Commercial Organization (CCO) to shorten the distance from “lab to life”.
Pharmacy Job Responsibilities
- Looking for min 2.5 years of experience in PV
- Should have ICSR case processing and Argus experience.
- Office-based opportunity
- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs as required. Assists
in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific procedures and safety plans as required. - Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory
reportability. Enters data into the safety database. - Codes events, medical history, concomitant medications, and
tests. - Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Maintains safety tracking for assigned activities.
- Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA
coding as required. - Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using
MedDRA. - Manual recoding of unrecoded product and substance terms arises from ICSRs.
Qualifications
- Bachelor’s Degree in pharmacy or an equivalent combination of education
and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job. - Safety Database systems and knowledge of medical terminology required.
- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements,
ICH GCP, GVP, and regulations related to Safety and Pharmacovigilance. - Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or
another management/shared content/workspace), and internet. - Ability to work independently and in a team environment.
- Excellent communication and interpersonal skills, both written and spoken.
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
