Safety & PV Specialist - Future Roles (Mexico)

Updated: Yesterday
Location: MEX-Mexico City-Hybrid

Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of IC
SRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages
ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database.
Codes events, 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.
- Maintains safety tracking for assigned activities.
- Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.




- Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
- Manual recoding of un-recoded product and substance terms arises from IC
SRs.
- Identification and management of duplicate IC
SRs.
- Activities related to SPOR / IDMP.
- Quality review of IC
SRs.
- 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 (WIs), general drug/biologic/device regulations, GCP,
ICH guidelines, GVP, project/program plans and the drug development process.
- Fosters constructive and professional working relationships with all project team members, internal and external.
- Participates in audits as required/appropriate.
- Applies safety reporting regulatory inte

📌 Safety & PV Specialist - Future Roles (Mexico) (Ciudad de México)
🏢 Syneos Health
📍 Ciudad de México