Safety Director jobs in Danbury, CT

Passionate about patient health and safety? We have an exciting opportunity for you!

Our dedicated TA CRM Team is looking for an experienced Executive Director of Patient Safety Physician with expertise in cardiovascular, renal, metabolic, and/or respiratory diseases. You'll work on a variety of products, both in clinical development and post-marketing drug safety. Ready to make a real difference in patient safety? We look forward to your application!

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Lead a team responsible for the development of proactive risk management strategies for a portfolio of core strategic (high profile and/ or high volume and/or high complexity) marketed and/or investigational products within cardiovascular, renal, metabolic, and/or respiratory diseases.
• Lead, manage, and provide medical-scientific direction to a team of Patient Safety Physicians responsible for a compound/asset, including project management, project-specific guidance, team coaching, and review of team output
• Develop proactive patient-centric risk minimization strategies for assigned assets on a global level
• Enhance the value of BI assets through robust assessment of the benefit-risk profile
• Design evidence strategies that differentiate the asset through its benefit-risk profile, considering the scientific knowledge for the molecule, medical safety landscape, population, regulatory landscape, and patient perspective
• Generate safety evidence and perform safety & efficacy analyses to support decision-making by patients, regulators, HCPs, payors, and HTA bodies
• Review and provide medical-scientific input to regulatory documents (e.g., PSURs, DSURs, RMPs, Clinical Overview Statements)
• Interpret clinical trial safety data for clinical trial reports and submission documents
• Establish strategic partnerships within the Asset and Evidence Network
• Ensure patient safety while adhering to the highest quality and ethical standards
• Represent PSPV in internal and external multidisciplinary committees & bodies
• Contribute to PSPV's development within BI by staying updated on methodology, regulatory changes, and healthcare trends

Requirements

• Medical Doctor (MD) from an accredited institution

• Profound experience in patient safety at a pharmaceutical company on a global/corporate level, including clinical development and post-marketing safety

• Comprehensive understanding of pharmacovigilance regulations in major markets and the need for compliance

• Broad understanding of the pharmaceutical industry, and interest in future trends and developments in pharmacovigilance

• Clinical or research experience in the cardio-renal-metabolic field

• Leadership, people management & project management skills

• Excellent collaboration, communication, and negotiation skills

• Strong ethical sense with a quality and patient safety mindset

Desired Skills, Experience and Abilities