Director-level pharmacovigilance scientist leading signal detection and safety surveillance for complex pharmaceutical products. Responsible for developing surveillance strategies, detecting emerging safety signals from post-marketing data, and collaborating across cross-functional teams to inform safety decisions.
Responsibilities
- Lead systematic signal detection and validation activities for assigned complex pharmaceutical products
- Prepare high-quality safety data reviews and communicate findings to medical safety officers and teams
- Develop and implement product-specific surveillance plans in collaboration with stakeholders
- Mentor Associate Director and provide training to Signal Management Group personnel
- Evaluate novel computer-assisted tools and methodologies for safety data analysis and pilot new approaches
Requirements
- Advanced degree in life science, pharmacy, or related field
- Extensive experience in pharmacovigilance, signal detection, or drug safety
- Demonstrated expertise with regulatory databases (FDA AERS, WHO VigiBase, EMA EudraVigilance)
- Strong scientific acumen and proficiency in safety data analysis methodologies
- Leadership experience managing safety surveillance programs or teams
- Excellent written and verbal communication skills for cross-functional collaboration
Vacancy posted 9 days ago
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