Associate Medical Director, Global Drug Safety

AstraZeneca • Mississauga, ON

4d • CA$123,960 - CA$162,698 • Hybrid

About The Position

This position is accountable for the timely preparation of high-quality regulatory compliant clinical document deliverables for Alexion Rare Disease Unit (Alexion). This position will support the medical writing (MW) activities for one or more clinical programs. This position will function with supervision and guidance from experienced managers or colleagues. At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Requirements

• Bachelor’s degree in a relevant scientific or healthcare discipline (or proven patient safety experience equivalence in a similar role)
• Experience in patient safety within pharmaceutical, hospital, clinical research, or healthcare settings (including Specialist roles within AstraZeneca Patient Safety)
• Thorough knowledge of patient safety processes and local regulations (e.g., FDA and ICH regulations relevant to patient safety and adverse event reporting)
• Broad competence with medical, therapeutic, and technical terminology
• Ability to work effectively as part of a cross-functional team
• Excellent verbal and written communication skills

Nice To Haves

• Advanced degree preferred
• Excellent knowledge of AstraZeneca policies, procedures, and guidelines
• Actively pursues continuing education within the Pharmaceutical Industry
• Proven ability to perform with some supervision

Responsibilities

• Lead and provide technical and scientific expertise for clinical or post marketing safety projects, process improvements, and departmental initiatives, including providing dotted-line or informal people leadership and ownership of small teams or project groups
• Manage and develop a patient safety team, guiding performance, supporting professional growth, and overseeing day-to-day activities
• Actively contribute to the development and execution of country, regional, or sub-functional patient safety strategies, ensuring alignment with organizational goals, and lead cross-functional and, where relevant, cross-country/region projects, serving as a bridge between subject matter expert and formal people leader
• Serve as a knowledge resource by sharing best practices, mentoring colleagues, and driving cross-functional collaboration within and beyond the team
• Support or oversee compliance with patient safety policies and regulations, ensuring thorough review and accuracy of safety documentation and submissions
• Apply analytical expertise to inform key decisions, drive reporting and quality initiatives, and contribute to continuous improvement efforts
• Assumes a supporting role in identifying patient safety-related issues and implementing solutions; supports business unit needs and patient safety by developing and maintaining partnerships with internal and external customers.
• Provides training and mentoring to Patient Safety Coordinators on local and global adverse event reporting and career development
• Works as a team player and supports the development of other team members; supports the interview process for prospective new team members.

Benefits

• Annual base salary for this position ranges from 123,960.00 to 162,697.50.
• Annual Variable Pay Bonus/Short Term Incentive opportunity
• Eligibility to participate in our equity-based long-term incentive program (if applicable to role)
• Competitive Flex Benefits & Retirement Savings Program
• 4 weeks’ paid vacation
• Annual Personal Days
• Contract Benefits Program (for Fixed Term Contract/Temporary positions excluding students)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager