Senior Manager, Safety Scientist
$132.87k - $199.31kAstraZeneca
AstraZeneca seeks a Senior Manager, Safety Scientist in Boston to evaluate and manage safety risks for assigned products throughout their lifecycle. The role involves coordinating safety data reviews, authoring regulatory documents, and leading safety surveillance activities in collaboration with cross-functional teams.
Responsibilities
- Contribute to safety data reviews and analyses for assigned therapeutic area products
- Author and review safety sections of clinical documents and aggregate regulatory reports
- Coordinate oversight of safety surveillance and implementation of Safety Strategy and Management Teams
- Lead signal analysis, safety reviews, and communication of safety findings to cross-functional bodies
- Support regulatory submissions through authoring and reviewing eCTD modules and product labeling
Requirements
- Bachelor's degree in biological, medical, clinical, or nursing field
- Minimum 3 years drug safety or pharmacovigilance experience
- Knowledge of global pharmacovigilance regulations
- Strong analytical, problem-solving, and scientific writing skills
- Ability to work independently with demonstrated learning agility
- Effective communication and collaboration across multiple disciplines globally
- Advanced degree (PharmD, Nurse Practitioner, or PhD) preferred
Compensation: $132,873-$199,310 base annual salary
Vacancy posted 17 days ago
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