Senior Pharmacovigilance Associate
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Descripcion del puesto
About the role
ICON is seeking a Senior Pharmacovigilance Associate to lead safety and efficacy activities for pharmaceutical products. This remote position based in Chile offers the chance to work within a sponsor‑dedicated model and contribute to global drug safety initiatives.
Key responsibilities
- Lead collection, evaluation, and processing of adverse event reports to ensure timely, accurate regulatory reporting.
- Analyze safety data, identify trends, and detect potential safety signals for further investigation.
- Prepare and submit periodic safety update reports (PSURs) and other regulatory documents in compliance with international regulations.
- Collaborate with medical and clinical teams on risk management and clinical relevance of adverse events.
- Maintain pharmacovigilance databases, ensuring data integrity and compliance with management standards.
- Provide training and mentorship to junior team members on pharmacovigilance processes and regulations.
- Support audits and inspections by regulatory authorities, ensuring readiness and compliance.
Required profile
- Bachelor's degree in a scientific or healthcare‑related discipline.
- Extensive experience in pharmacovigilance or drug safety with strong knowledge of regulations and industry standards.
- Proven ability to manage pharmacovigilance processes, including adverse event reporting and signal detection.
- Strong analytical, critical thinking, and communication skills.
- Ability to work independently, manage multiple priorities, and travel up to 15% as needed.
Required skills
- Proficiency with pharmacovigilance databases and data management systems.
- Advanced use of Microsoft Office Suite.
What we offer
- Competitive base salary and performance‑related incentives.
- Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans, life assurance, and disability coverage.
- Employee assistance programmes and wellbeing resources.
- Learning and development opportunities through structured training and career pathways.
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Publicado hace 13 horas
Expira en 1 mes
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