Lead Safety Medical Writer
Il y a 2 mois
Join Baxter in a Pioneering Role
Baxter is seeking a Lead Safety Medical Writer to enhance our commitment to advancing kidney care and organ support. In this pivotal role, you will be tasked with the preparation, quality assurance, and dissemination of aggregate safety reports (ASRs) and pharmacovigilance risk management plans (PV-RMPs) for global regulatory compliance.
Key Responsibilities:
- Draft and compile post-marketing aggregate safety reports for regulatory purposes
- Ensure adherence to regional regulatory standards
- Oversee document review and approval processes
- Guide cross-functional project teams
- Assist in audits and regulatory inspections
- Contribute to the development of standardized departmental protocols
- Conduct safety analyses and surveillance activities
- Offer medical insights across various functional departments
Qualifications:
- Medical degree with a minimum of 2 years of experience in the pharmacovigilance sector
- Experience in authoring ASRs and PV-RMPs is preferred
- Exceptional scientific and clinical writing abilities
- Strong interpersonal and communication skills
- Thorough understanding of pharmacovigilance regulations
- Proven ability to manage project timelines efficiently
- Collaborative team player with a global perspective
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