Job Posting Title Local Pharmacovigilance Excellence Specialist, LPV
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Coordinate communications and support Local Pharmacovigilance Organizations on operational tasks related to the Global Safety Database. Act as a Subject Matter Expert for reporting rules, translating regulatory requirements into local reporting rules and maintaining bi-annual revisions. Investigate Reporting Rule and Global Safety System issues, identify areas for improvement, and make resolution recommendations. Develop, update, and implement global procedures for LPV while ensuring audit and inspection readiness by responding to queries. Partner with Global Safety Reporting Teams and stakeholders to ensure a consistent global approach to safety.
Required Qualifications
- Medical/ Health Sciences and/or proven equivalent experience in pharmacovigilance and safety issue management
- A minimum of 5 years' experience
- Fluent communication skills in English
- Computer literate with knowledge of relevant IT safety systems
- Strong ARGUS expertise
- hands-on experience in the setup and maintenance of reporting rules
- Ability to effectively partner with and support LSOs and stakeholders globally
- Strong stakeholder management, problem-solving, and communication skills
- Proven ability to organize workflow activities
- Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology
- Knowledge of global, regional, and local procedural documents as applicable
- Good verbal and written communication skills
- Ability to establish and maintain open relationships within the organization
Desired Qualifications
- any additional language
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