Pharma Job at Syneos Health | Apply Now for the Safety & PV Specialist Role
Syneos Health is hiring a Safety & PV Specialist I for multiple locations in India (Gurugram, Hyderabad, Pune) for an Office-based, Full-Time role. This Pharma Job is crucial for the Pharmacovigilance (PV) safety team, requiring expertise in processing Individual Case Safety Reports (ICSRs). Candidates must possess a Bachelor’s Degree in Life Science, Nursing, or Pharmacy and a good understanding of GCP, GVP, and ICH guidelines. In the Syneos career, the specialist will be responsible for case triage, data entry into the safety database, MedDRA coding, and ensuring timely expedited reporting in compliance with global regulations, which makes this position a prime example of a pharma job opportunity.
- Job Post: Safety & PV Specialist I
- Location: Gurugram, Hyderabad, Pune
In this rewarding pharma job, you will grow your skills in a supportive environment focused on quality and innovation.
Syneos career Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into 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, MedDRA coding as required.
- Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA, is an integral task in this pharma job role.
- Manual recoding of un-recoded 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.
- 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:
- 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.
- For this Syneos Career, ability to work independently and in a team environment is important.
- Excellent communication and interpersonal skills, both written and spoken.
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects. In conclusion, this pharma job requires excellent management skills.
- Detail oriented with a high degree of accuracy and ability to meet deadlines.
