Bristol-Myers Squibb

Executive Director, Head of Pharmacovigilance - Safety Science

San Diego, California, United States

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries

Requirements

Candidates should possess a Bachelor’s degree in Pharmacy, Pharmacology, or a related scientific field, and hold a minimum of 10 years of experience in pharmacovigilance, with at least 5 years in a leadership role. Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines, is essential, along with demonstrated expertise in safety data analysis and risk management.

Responsibilities

The Executive Director, Head of Pharmacovigilance - Safety Science will develop and lead the global pharmacovigilance strategy, overseeing safety operations and ensuring compliance with regulatory requirements. They will also direct safety evaluation and risk management for clinical development and post-marketing products, lead the detection and assessment of safety signals, and collaborate with cross-functional teams to support the safe use of products globally.

Skills

Pharmacovigilance
Global Pharmacovigilance Regulations
FDA
EMA
ICH Guidelines
Safety Data Analysis
Risk Management
Safety Signal Detection
Clinical Development
Post-Marketing Products

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

Key Metrics

New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Benefits

Flexible Work Hours
Hybrid Work Options
Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.
BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.
Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.
The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.
BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.
The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.
BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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