PV-Clinical New
Monroe Consulting Group Manila
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.
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
OptumManila
ROLE AND RESPONSIBILITIES
About the Role
We are looking for a Licensed Pharmacist to join our healthcare team as a Clinical Content Analyst. In this role, you will be responsible for developing, reviewing, and maintaining evidence-based clinical...
Taguig, 12 km from Manila
ONLY THOSE APPLICANTS WHO ALREADY HAVE THE RIGHT TO LIVE AND WORK IN THIS COUNTRY ARE ELIGIBLE TO APPLY FOR THIS ROLE---
POSITION TITLE: Health Clinical Services Sr Analyst
WORK SETUP: Return to Office
RESPONSIBILITIES:
• Conduct UM pre...
BruntWorkManila
Job Overview:
We are seeking an experienced, patient-focused Clinical Support Assistant to provide critical administrative and operational support throughout our medical cannabis certification process. Acting as the central link between patients...