Pharmacovigilance Analyst – Mid-level
LIBBS FARMACÊUTICA LTDA
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇧🇷 Brazil
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Develop internal procedures that ensure compliance with health regulations and International Good Pharmacovigilance Practices (GVP), covering all activities within the area.
- Process adverse event reports according to internal procedures and timelines.
- Ensure analysis of safety data for marketed or investigational products, recording pharmacovigilance reports in the internal database according to established procedures.
- Prepare benefit–risk assessment reports and risk management plans for regulatory authorities, containing critically analyzed internal and external data to provide visibility into product safety profiles.
- Align processes with commercial partners, ensuring adherence to internal procedures and operational feasibility with available resources.
- Ensure appropriate collection and management of pharmacovigilance data by interfacing departments, establishing workflows that meet internal needs and regulatory deadlines.
- Provide visibility into the management of potential risks or safety concerns by conducting safety signal detection processes.
- Implement actions to ensure adequate product risk management.
- Contribute to product label and package insert review processes, providing guidance on the safe use of medicines.
Requirements
- Bachelor's degree or higher in a health-related field.
- Three years of experience in pharmacovigilance.
- Advanced English proficiency.
- Solid knowledge of International Good Pharmacovigilance Practices (GVP).
- Experience preparing Periodic Benefit–Risk Evaluation Reports (PBRERs).
- Experience with ArisGlobal (LifeSphere) system.
Benefits
- Meal voucher.
- Food allowance.
- Libbs medications – 100% coverage.
- Vidalink pharmacy program.
- PPR – Company Profit and Results Sharing Program (profit-sharing).
- Parking, commuting allowance (transit voucher) or company shuttle (applicable only for shift work).
- USE Program: subsidy for purchasing equipment to be used for work, which may also be used for personal purposes.
- Flexible benefits (TotalPass), life insurance, private pension, health insurance, dental care and meal assistance.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilancesafety data analysisbenefit-risk assessmentrisk management planssafety signal detectionPeriodic Benefit–Risk Evaluation Reports (PBRERs)compliance proceduresdata management
Soft skills
communicationcollaborationanalytical thinkingattention to detail