Director Pharmacovigilance Safety Operations
Director Pharmacovigilance Safety Operations
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Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving 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: with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving teams rich in diversity. 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: 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 against targets of solid tumors. Led by a successful and experienced entrepreneurial team RayzeBio aims to be the global leader inradiopharmaceuticals.
The Director of Pharmacovigilance Safety Operations will be responsible for overseeing and managing the pharmacovigilance activities to ensure the safety of our products and compliance with regulatory requirements. This role involves working closely with clinical science clinical operations and regulatory affairs to ensure accurate and timely reporting of adverse events and implementing effective risk management strategies. This role requires supporting NDA filing inspection and product launches
Key Responsibilities
Safety Surveillance: Oversee the collection assessment and reporting of adverse events and other safety data from clinical trials and postmarketing sources. Oversee CROs and vendor management of case processing and ensure timely review and reporting of AEs SAEs SUSARs etc
Quality and compliance: Support safety database processes and transfers to ensure the integrity of the safety database
Regulatory Compliance: Ensure compliance with global pharmacovigilance regulations and guidelines including timely submission of safety reports to regulatory authorities. Support NDAs and health authority third party inspections.
Risk Management: Develop and implement risk management plans including signal detection risk assessment and risk minimization activities.
Stakeholder Collaboration: Collaborate with internal and external stakeholders including regulatory authorities healthcare professionals and parent company to ensure effective communication and management of safety issues. Oversee business partner safety operations requirements e.g. safety data exchange pharmacovigilance agreements.
Process Improvement: Continuously evaluate and improve pharmacovigilance processes and systems to enhance efficiency and effectiveness. Manage safety CROs and vendors to ensure quality services meeting compliance and cost efficient processes.
Documentation and Reporting: Ensure accurate and comprehensive documentation of safety data and prepare periodic safety update reports (PSURs) development safety update reports (DSURs) and other required regulatory submissions.
Training and Development: Provide training to internal teams and external partners on pharmacovigilance practices and regulatory requirements. W
Qualifications
Masters degree in a scientific or healthcarerelated field is required (MD PharmD or PhD is preferred).
Minimum of 10 years of experience in pharmacovigilance and safety operations
Indepth knowledge of global pharmacovigilance regulations and guidelines (e.g. ICH GVP FDA EMA).
Proven track record of successful collaboration with regulatory authorities and other stakeholders.
Experience in safety operations support to NDA filing and product launches.
Excellent leadership communication and interpersonal skills.
Strong analytical and problemsolving abilities.
Ability to work effectively in a fastpaced dynamic environment.
#RayzeBio
If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work Lifechanging Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign roles may be eligible for a hybrid work model with at least 50 onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For fieldbased and remotebydesign roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Director
Employment Type
Full-Time
