Senior Director, Safety MD

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $306.8k - $371.8k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Provide medical safety leadership across clinical development and pharmacovigilance activities • Lead or co-lead global pharmacovigilance strategy, proactive safety surveillance, signal detection, risk management, and regulatory compliance • Establish and maintain safety governance structures, SOPs, and continuous improvement processes • Partner with safety, clinical development, regulatory, medical affairs, and cross-functional teams • Direct safety evaluation and benefit-risk assessment for clinical development and post-marketing products • Represent Safety Science in safety management teams, study meetings, health authority interactions, submissions, safety reports, audits, and inspections • Drive safety content for protocols, investigator brochures, DSURs, PSURs, RMPs, ICFs, RSLs, CSRs, regulatory filings, and responses to inquiries • Perform daily ICSR/SAE case reviews and support safety management across clinical trial phases • Serve as a PV representative for regulatory authorities, external experts, scientific bodies, and industry groups • Mentor cross-functional colleagues, direct reports, and safety team members • Leverage AI to improve program, portfolio, or functional performance • Serve as backup Safety MD for the PV Head

🎯 Requirements

• MD or equivalent • 10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry • Knowledge/awareness of current global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH • Expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting • Experience interacting with global regulatory authorities and scientific advisory bodies • Strong leadership and communication skills • Ability to work effectively in a matrixed, cross-functional environment • Commitment to patient safety and ethics in medical practice • 25% travel

🏖️ Benefits

• Discretionary incentive cash • Stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life, and disability insurance offerings • Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees • 11 paid company holidays • 160 hours of paid vacation annually for new hires for eligible non-exempt, RayzeBio, and Puerto Rico employees • 3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees • Paid sick leave • Up to two paid volunteer days per year • Summer hours flexibility • Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs • Annual Global Shutdown between Christmas Day and New Year's Day • Reasonable workplace accommodations/adjustments and ongoing support