Safety and Pharmacovigilance Specialist II Position

hace 2 semanas

Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo

Syneos Health Job Overview

Safety & Pharmacovigilance Specialist II Role Summary

We are seeking a Safety & Pharmacovigilance Specialist II to join our team at Syneos Health. This role will be responsible for ensuring the high-quality safety reporting and pharmacovigilance activities for our clients.

Responsibilities:

  1. Enter information into PVG quality and tracking systems for receipt and tracking of ICSR as required.
  2. May assist in the preparation of project plans such as Safety Management Plan.
  3. May perform set-up, delivery, and close-out of safety and pharmacovigilance projects.
  4. Process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
  5. Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory report ability.
  6. Enter data into safety database.
  7. Code events, medical history, concomitant medications, and tests.
  8. Compile complete narrative summaries.
  9. Assess information to be queried and follow up until information is obtained and queries are satisfactorily resolved.
  10. Participate in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
  11. Coordinate with data management staff concerning reconciliation of safety data between the clinical and safety databases.
  12. Maintain safety tracking for assigned activities.
  13. Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required.
  14. Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
  15. Manual recoding of un-recoded product and substance terms arises from ICSRs.
  16. Identification and management of duplicate ICSRs.
  17. Activities related to SPOR / IDMP.
  18. Quality review of ICSRs.
  19. Quality review for the work performed by peers.
  20. Foster constructive and professional working relationships with all project team members, internal and external.
  21. Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
  22. Ensure distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
  23. Participate in audits/inspections as required.
  24. Ensure 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.
  25. Maintain 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.

Requirements:

  1. 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.
  2. Safety Database systems and knowledge of medical terminology required.
  3. 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.
  4. Ability to work independently and in a team environment.
  5. Excellent communication and interpersonal skills, both written and spoken.
  6. Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
  7. Detail-oriented with a high degree of accuracy.

About Syneos Health

At Syneos Health, 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.

We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Why Syneos Health?

At Syneos Health, 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.

We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Apply Now

If you are passionate about developing your career in pharmacovigilance and safety, join our team at Syneos Health. We are seeking a qualified and motivated individual to fill this Safety & Pharmacovigilance Specialist II role.

Apply online today

Link to apply: [Insert link to apply]

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