Pharma Job at Syneos Health | Apply Now for the Safety & PV Coordinator Role
Syneos Health is inviting applications for the position of Safety & PV Coordinator at its Hyderabad office. This Pharma Job is exclusively open to B.Pharm/M. Pharm graduates with at least one year of experience in Post-Marketing Surveillance (PMS) and spontaneous case processing. The successful candidate will manage ICSR triage, safety database entry (LSMV/Argus), and MedDRA coding to ensure global regulatory compliance and patient safety in this Syneos Job.
- Job Role: Safety & PV Coordinator
- Location: Serilingampalli, Telangana
About the Company
Syneos Health is a global powerhouse built to accelerate customer success by translating clinical, medical affairs, and commercial insights into real-world outcomes. With 29,000 employees across 110 countries, the organization operates on a “Total Self” culture that encourages authenticity and diversity. For those pursuing a Pharma Job, Syneos Health provides opportunities in both FSP partnership and full-service environments, with employees dedicated to changing lives through rapid therapy delivery.
Job Responsibilities
- 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 safety plans as required. If you’re seeking a Pharma Job, these responsibilities offer a strong professional foundation.
- 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.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. For candidates seeking a Pharma Job, these tasks are essential for compliance.
- Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process.
- Fosters constructive and professional working relationships with all project team members, internal and external.
- Participates in audits as required/appropriate.
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Qualifications
- Education: B.Pharm/M.Pharm only. For Pharma Job applicants, these qualifications are mandatory.
- Office Location: Hyderabad
- Experience: Minimum 1 year of experience in PMS and Spontaneous cases
- Preferred Database: LSMV, fine to proceed with Argus
- 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. Having these skills is crucial for any Pharma Job.
- 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.
- Detail-oriented with a high degree of accuracy and ability to meet deadlines. These characteristics are highly valued in any Pharma Job.
