Safety & Pv Specialist- Future Roles (india)

Syneos Health

India
On-site
Enter information into pvg quality systems
Processing of icsrs according to sops
Triage icsrs and evaluate data
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success

Job Summary

  • Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

Matching Summary

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

Skills & Requirements

Must-have

  • Enter information into PVG quality systems
  • Processing of ICSRs according to SOPs
  • Triage ICSRs and evaluate data
  • Enter data into safety database
  • Code events, medical history, medications
  • Compile complete narrative summaries
  • Generate timely, consistent, and accurate reporting
  • Maintain safety tracking for assigned activities
  • Perform literature screening and review
  • Validation and Submission of xEVMPD product records
  • Manual recoding of un-recoded product terms
  • Identification and management of duplicate ICSRs
  • Quality review of ICSRs
  • Submit relevant documents to TMF
  • Maintain understanding and compliance with SOPs
  • Foster constructive and professional working relationships
  • Participate in audits as required
  • Apply safety reporting regulatory intelligence

Nice-to-have

  • Accelerate customer success
  • Translate insights into outcomes
  • Develop people through career progression
  • Supportive and engaged line management
  • Technical and therapeutic area training
  • Peer recognition and total rewards
  • Commitment to Total Self culture
  • Build a company everyone wants to work for
  • Bring together diversity of thoughts

Key Requirements

  • Bachelor’s Degree in life science, RN, pharmacist or equivalent
  • Safety Database systems knowledge
  • Medical terminology knowledge
  • Good understanding of clinical trial process
  • Proficiency in Microsoft Office Suite
  • Ability to work independently and in a team
  • Excellent communication and interpersonal skills
  • Good organizational skills
  • Detail oriented with high accuracy
  • Ability to meet deadlines

Work Rights

Not specified

Tailored Resume

Cover Letter