Syneos Health Hiring for Safety & PV Specialist I/II – Argus – Early Joiner
Location :- Hyderabad
Requirement Details :-
Bachelor’s Degree in life science, registered nurse, pharmacist 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), TeamShare (or other management/shared content/workspace) and internet.
• Ability to work independently and in a team environment
Good 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
Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
Job Responsibilities :-
• Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
• Assists in the processing of ICSRS according to Standard Operating Procedures (SOPs) and project/ program-specific safety plans. Triages ICSRS, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
• Enters data into safety database.
▪ Codes ents, 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.
• 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 (Wls), global drug/biologic/device regulations, GCPS, ICH guidelines, GVP, project/program plans and the drug development process.
Application process :-
Check out this job at Syneos Health: https://www.linkedin.com/jobs/view/2639237297