Lead Patient Safety Physician - CRM

BoehringerPRD•Brampton, ON

5d•$280,000 - $441,000

About The Position

The Lead Patient Safety Physician is responsible for pharmacovigilance risk management activities for marketed and/or investigational compounds on a global level. This role may encompass a portfolio of products or investigational compounds within a specific disease area or therapeutic area. In addition to reporting to US line management, this position may have a matrix reporting structure to a Head Risk Management TA X, Global Pharmacovigilance. As an employee of Boehringer Ingelheim, you will contribute to the discovery, development, and delivery of our products. Our global presence offers opportunities for international collaboration, visibility, and direct contribution to the company's success. We recognize that our strength lies in our people and support employees through various initiatives to foster a healthy work environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect our commitment to our employees.

Requirements

US MD or DO degree or international equivalent from an accredited institution.
Completion of a US residency or ex-US equivalent.
Active or inactive US license to practice medicine or international equivalent.
Total applicable experience (including clinical practice, research, or relevant industry) of greater than five (>5) years.
Minimum of two (2) years of experience in the pharmaceutical industry or equivalent (preferably pharmacovigilance) required.
One to three (1-3) years of leadership experience (e.g., projects, teams, initiatives) and influencing teams required.
Potential for people leadership required.
Strong leadership skills and executive presence required.
Excellent interpersonal and communication skills (both written and oral) required.
Ability to attend key meetings in person required.
Highly ethical personality putting patient safety first.
Self-starter and driving personality, willingness to take on responsibilities.
Sound medical-scientific and clinical knowledge and judgment.
Ability to synthesize large amounts of medical data, draw medical conclusions, and clearly communicate the conclusions.
Thorough understanding (based on experience) of Pharmacovigilance and Risk Management in a major pharmaceutical company on a global/corporate level, including safety in clinical development and post-marketing safety.
Thorough understanding of Pharmacovigilance regulation in major markets and respective need for compliance.

Nice To Haves

People leadership experience preferred.
International experience/international exposure in daily business preferred.
Board certification/experience in a medicine sub-specialty would be an asset.

Responsibilities

Develop proactive risk management strategies for assigned marketed and/or investigational compounds.
Set and align standards across products/compounds within the assigned portfolio.
Plan, manage/perform, and monitor all pharmacovigilance activities for assigned drug responsibilities.
Oversee and ensure implementation of pharmacovigilance activities across the assigned portfolio, including continuous monitoring and further development of the product safety profile, safety issue management, and setup of safety analyses in postmarketing and clinical trial databases.
Collaborate closely with Global Epidemiology and Medical Affairs on safety-focused clinical and epidemiological studies.
Review and provide medical-scientific input to regulatory documents such as safety components of submission documents for global marketing authorization, Periodic Benefit Risk Evaluation Reports/PADERs, Development Safety Update Reports, Risk Management Plans, and Clinical Overview Statements.
Chair the BI-internal Pharmacovigilance Working Group, comprising experts in Pharmacovigilance, Medical Affairs, Epidemiology, Biostatistics, and other relevant disciplines.
Strategically lead, manage, and medically/scientifically direct a team of risk management physicians responsible for an investigational compound, product, or portfolio compound/product/project, including project management, training, and coaching.
Provide updates or coach direct reports to update senior management on the assigned drug's safety profile and recommend pharmacovigilance/risk management activities to BI decision-making bodies and the EU QPPV.
Represent Global Pharmacovigilance in internal and external committees and bodies, potentially including high-profile committees such as FDA advisory committees, global regulatory authority meetings, Advisory Boards, Board of Managing Directors, and congresses.
Contribute to the further development of pharmacovigilance within BI by staying abreast of state-of-the-art methodology, regulatory changes, and healthcare trends.
Lead strategic projects within GPV (e.g., future software solutions, strategic initiatives, addressing changing global regulatory environments).
Represent PV at US-specific cross-functional meetings requiring Risk Management support (e.g., MAT, TASC) and serve as a liaison from the team to VP, GPV-US, providing regular updates to US teams and leadership.
Contribute to strategic planning regarding US Risk Management topics.
Act as a designee/substitute for VP, GPV-US or Global Risk Management Therapeutic Area Head at US meetings.
Accountable for proactive risk management of assigned key marketed and/or investigational compounds or product families, including continuous assessment of the benefit-risk profile and performing risk minimization as required to ensure safe use in patients.
Ensure thorough understanding of Pharmacovigilance regulation in major markets and respective compliance needs.