PV-Clinical
Empresaria Group PLC ·www.empresaria.com
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Executive Search Firm Monroe Consulting Group is recruiting a Pharmacovigilance Associate on behalf of a multinational company who specializes in patient-centric drug development and commercialization services, aiming to provide reliable clinical research solutions to pharmaceutical and biotech firms. The Pharmacovigilance Associate is responsible for the intake, processing, and management of safety cases arising from clinical trials. This role focuses on accurate documentation, evaluation, and reporting of adverse events in compliance with global pharmacovigilance regulations, study protocols, and company procedures. Working setup is fully remote.
Essential Functions:
• Perform case intake, triage, and data entry of adverse events, serious adverse events, and SUSARs from clinical trial sources
• Process safety cases in accordance with regulatory guidelines, study protocols, and internal standard operating procedures
• Review and interpret source documents including CIOMS forms, MedWatch reports, investigator communications, and clinical trial documentation
• Conduct medical review of cases and perform causality and expectedness assessments based on investigator reports and protocol requirements
• Perform case follow up with investigators or study teams to obtain missing information and ensure data completeness
• Manage safety queries and ensure timely resolution of case discrepancies
• Prepare and submit expedited safety reports to regulatory authorities, ethics committees, and investigators within required timelines
• Maintain accurate documentation and ensure compliance with global pharmacovigilance standards and reporting regulations
Qualifications:
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field preferred.
• Experience in pharmacovigilance case, at least 1 year experience in processing within clinical trials
• Strong understanding of adverse event reporting, serious adverse events, and SUSAR reporting requirements
• Familiarity with global safety reporting regulations and clinical trial safety procedures
• Experience reviewing clinical safety documentation such as CIOMS and MedWatch forms
• Strong attention to detail and ability to meet strict regulatory timelines
Safety Database Experience:
• Argus Safety
• ARISg
• PV Edge
• Veeva Vault Safety
• EDC databases
Essential Functions:
• Perform case intake, triage, and data entry of adverse events, serious adverse events, and SUSARs from clinical trial sources
• Process safety cases in accordance with regulatory guidelines, study protocols, and internal standard operating procedures
• Review and interpret source documents including CIOMS forms, MedWatch reports, investigator communications, and clinical trial documentation
• Conduct medical review of cases and perform causality and expectedness assessments based on investigator reports and protocol requirements
• Perform case follow up with investigators or study teams to obtain missing information and ensure data completeness
• Manage safety queries and ensure timely resolution of case discrepancies
• Prepare and submit expedited safety reports to regulatory authorities, ethics committees, and investigators within required timelines
• Maintain accurate documentation and ensure compliance with global pharmacovigilance standards and reporting regulations
Qualifications:
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field preferred.
• Experience in pharmacovigilance case, at least 1 year experience in processing within clinical trials
• Strong understanding of adverse event reporting, serious adverse events, and SUSAR reporting requirements
• Familiarity with global safety reporting regulations and clinical trial safety procedures
• Experience reviewing clinical safety documentation such as CIOMS and MedWatch forms
• Strong attention to detail and ability to meet strict regulatory timelines
Safety Database Experience:
• Argus Safety
• ARISg
• PV Edge
• Veeva Vault Safety
• EDC databases
Frequently asked questions
Who is hiring for the PV-Clinical role?
Empresaria Group PLC is hiring for the PV-Clinical position, a Shazamme client. Apply directly on the employer's career site.
Where is the PV-Clinical job located?
The PV-Clinical role with Empresaria Group PLC is based in TBA, US. The role is remote-friendly.
Is the PV-Clinical role remote?
Yes — the PV-Clinical position at Empresaria Group PLC is remote. Candidates based in US are preferred.
Is the PV-Clinical role full-time or contract?
This is a full time position at Empresaria Group PLC.
What experience level is the PV-Clinical role?
The PV-Clinical position is aimed at mid-level candidates.
How do I apply for the PV-Clinical role at Empresaria Group PLC?
Apply directly on Empresaria Group PLC's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.