Director, Pharmacovigilance Safety Operations

Bristol Myers Squibb; Canada; Hybrid; CAD 90,000 - 160,000; Full time

Job summary

An established industry player is seeking a Director of Pharmacovigilance Safety Operations to lead safety activities that ensure product safety and regulatory compliance. This role involves overseeing adverse event reporting, collaborating with regulatory authorities, and implementing risk management strategies. Join a dynamic team dedicated to transforming patient lives through innovative therapies, where your expertise will be valued and your career can thrive. Embrace the opportunity to make a meaningful impact in a supportive and inclusive work environment.

Qualifications

• 10+ years of pharmacovigilance and safety operations experience.
• Deep knowledge of global pharmacovigilance regulations.

Responsibilities

• Oversee collection and reporting of adverse events from clinical trials.
• Develop and implement risk management plans.

Skills

Pharmacovigilance

Regulatory Compliance

Risk Management

Leadership

Analytical Skills

Communication Skills

Problem-Solving

Education

Master's degree in a scientific or healthcare-related field

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

About RayzeBio

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Position: Director of Pharmacovigilance Safety Operations

The Director of Pharmacovigilance Safety Operations will oversee pharmacovigilance activities to ensure product safety and regulatory compliance. Responsibilities include working with clinical science, operations, and regulatory affairs to ensure accurate reporting of adverse events, implementing risk management strategies, supporting NDA filings, inspections, and product launches.

Key Responsibilities

1. Safety Surveillance: Oversee collection, assessment, and reporting of adverse events from clinical trials and post-marketing sources. Manage CROs and vendors for case processing, ensuring timely review and reporting of AEs, SAEs, SUSARs.
2. Quality and Compliance: Support safety database processes and transfers to ensure data integrity.
3. Regulatory Compliance: Ensure adherence to global pharmacovigilance regulations, support safety reports submissions, NDA, and inspections.
4. Risk Management: Develop and implement risk management plans, including signal detection and risk minimization.
5. Stakeholder Collaboration: Work with regulatory authorities, healthcare professionals, and partners to manage safety issues and safety data exchange agreements.
6. Process Improvement: Continually evaluate and improve pharmacovigilance processes and systems, manage CROs and vendors for quality and cost efficiency.
7. Documentation and Reporting: Ensure accurate safety data documentation and prepare regulatory safety reports.
8. Training and Development: Provide pharmacovigilance training to teams and partners.

Qualifications

• Master's degree in a scientific or healthcare-related field (MD, PharmD, PhD preferred).
• Minimum 10 years of pharmacovigilance and safety operations experience.
• Deep knowledge of global pharmacovigilance regulations (ICH, GVP, FDA, EMA).
• Proven collaboration with regulatory authorities and stakeholders.
• Experience supporting NDA filings and product launches.
• Strong leadership, communication, and interpersonal skills.
• Excellent analytical and problem-solving skills.
• Ability to operate effectively in a fast-paced environment.

Additional Information

If a role interests you but isn't a perfect match, we encourage you to apply. You might be one step away from a transformative career opportunity.

Our Culture and Work Environment

We are committed to diversity, inclusion, and supporting our employees' well-being. Our occupancy structure varies by role, including onsite, hybrid, and remote options. We support reasonable accommodations for applicants with disabilities. We also recommend vaccination against Covid-19 for employee safety. For more details, visit our EEO and accessibility page.