Description
Syneos Health is seeking a Safety & PV Specialist I to join their team in Gurugram or Hyderabad. The successful candidate will be responsible for ensuring the timely and accurate reporting of safety information.
The role involves entering information into PVG quality and tracking systems, processing ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans, triaging ICSRs, evaluating ICSR data for completeness and accuracy, and maintaining safety tracking for assigned activities.
Key responsibilities include:
- Processing ICSRs and entering data into safety databases
- Coding events, medical history, concomitant medications, and tests
- Compiling narrative summaries and identifying information to be queried
- Generating timely and accurate reports in accordance with regulatory requirements
- Maintaining safety tracking and performing literature screening and review
- Validating and submitting xEVMPD product records and manually recoding product and substance terms
The ideal candidate will have:
- A Bachelor's degree in life sciences, nursing, pharmacy, or equivalent
- 2-4 years of experience in ICSR case processing, preferably in post-marketing CP
- Knowledge of safety database systems and medical terminology
- Understanding of clinical trial processes and safety requirements
- Proficiency in Microsoft Office Suite and ability to work independently and in a team
Syneos Health offers a dynamic work environment where employees can develop their careers and contribute to the company's mission of accelerating customer success.
Benefits
While specific benefits are not detailed in the job posting, Syneos Health mentions that they offer career development opportunities, supportive line management, technical and therapeutic area training, peer recognition, and total rewards programs.
Company Culture
Syneos Health values diversity, equity, and inclusion, fostering a culture where employees can authentically be themselves. They prioritize delivering high-quality solutions and have a strong commitment to compliance and regulatory requirements.