Be an early applicantLess than 25 applicants

Company

Bristol Myers Squibb · 1 week ago

Vice President, Head of Pharmacovigilance - Safety Science

Brisbane, CA

Full-time

Hybrid

Director/Executive

$332K/yr - $390K/yr

15+ years exp

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Responsibilities

Develop and lead the global pharmacovigilance strategy to ensure proactive risk management and compliance with local and international PV regulations (e.g., FDA, EMA, ICH).

Oversee end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment.

Establish and maintain robust safety governance structures, ensuring alignment with company objectives and industry best practices.

Direct safety evaluation and risk management for clinical and post-marketing products, including benefit-risk assessments, aggregate reporting, and product safety strategy.

Lead the detection, evaluation, and management of safety signals, collaborating with cross-functional teams to implement risk minimization strategies and communicate potential safety concerns.

Oversee safety aspects of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.

Partner with clinical, regulatory, and medical affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies.

Act as the key PV representative for interactions with global regulatory authorities and stakeholders, advocating for patient safety.

Engage with external experts, scientific bodies, and industry groups to stay updated on evolving PV practices and enhance the organization's safety profile.

Lead and mentor a high-performing pharmacovigilance and safety science team, fostering a culture of collaboration, accountability, and scientific excellence.

Define and implement processes for continuous improvement within PV operations, safety science, and risk management.

Manage the PV budget, ensuring alignment with organizational priorities and effective use of resources.

Up to 25% travel if not located in San Diego.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

PharmacovigilanceSafety ScienceRisk ManagementSignal DetectionRegulatory SubmissionsOncology ExperiencePatient Safety CommitmentStrategic Thinking

Required

MD, PharmD, PhD, or other advanced degree in a relevant field.

15+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry, with a proven track record of leadership.

Experience in Solid Tumors Oncology is required.

In-depth knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH.

Strong understanding of clinical development, post-marketing safety, and regulatory submissions.

Demonstrated expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting.

Experience interacting with global regulatory authorities and scientific advisory bodies.

Exceptional leadership, strategic thinking, and communication skills.

Preferred

Experience leading a large team within a global organization.

Proven ability to work effectively in a matrixed, cross-functional environment.

Demonstrated commitment to patient safety and ethics in medical practice.

Benefits

Competitive benefits, services and programs

Flexibility in our work environment

Company

Bristol Myers Squibb

Glassdoor

3.8

At Bristol Myers Squibb, we work every day to transform patients’ lives through science.

Founded in 1887

New York, New York, USA

10001+ employees

http://www.bms.com

H1B Sponsorship

Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2023 (152)

2022 (172)

2021 (188)

2020 (188)