Work as Safety & PV Coordinator at Syneos Health - Pharma, Life Science Apply

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Post : Safety & PV Coordinator (Officebased-1-2 years of experience)

Job Description
• Monitors and routes incoming information to the appropriate project
• Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes.
• Redacts patient identifying information/ images in accordance with data protection guidelines, ICH GCP and GVP.
• Enters data into the safety database in accordance with Sponsor/customer specific guidelines and Company standards.
• Ensures current conventions are followed when entering cases into the Safety database.
• Performs file creation, tracking, retention, and maintenance (paper and electronic).
• Manages the translation process for any source documents requiring translation.
• Performs or assist with query follow up process as instructed
• Assists with submission processes as required
• Assists with daily workflow reconciliation
• Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.

Candidate Profile
• Minimum 1-2 years of experience in ICSR case processing
• 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.
• 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.

Additional Information
Experience : 1-2 years
Qualification : Bachelor’s Degree in life science, registered nurse, pharmacist
Location : Hyderabad-Raheja-Mindspace
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : 25003047
End Date : 15th June 2025