
Pharmacovigilance Data Specialist
Há 3 dias
Job Summary:
A dedicated and detail-oriented professional sought to support the collection, processing, and reporting of safety data for clinical trials and marketed products as a Pharmacovigilance Assistant II.
Key Responsibilities:
- Ensure accurate and timely reporting of adverse events in compliance with regulatory requirements.
- Manage pharmacovigilance databases by reviewing reports for consistency and completeness, and maintaining accurate data entry.
- Assist in preparing periodic safety reports, including risk-benefit analyses, for regulatory submissions and sponsors.
- Collaborate with internal teams and external stakeholders to resolve queries related to safety data and pharmacovigilance activities.
- Support audit and inspection readiness by maintaining comprehensive documentation of pharmacovigilance activities and safety reports.
Requirements:
- Bachelor's degree in life sciences, pharmacy, or a related field.
- Previous experience in pharmacovigilance or drug safety with a solid understanding of regulatory requirements and safety reporting processes.
- Excellent attention to detail and strong organizational skills with the ability to manage complex data sets and reports.
- Strong communication and teamwork skills with experience collaborating across cross-functional teams and external partners.
- Ability to work in a fast-paced environment ensuring compliance with regulatory guidelines and timelines.
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