Senior Patient Safety Physician - Ophthalmology

Boehringer Ingelheim; Biberach an der Riß; Hybrid; EUR 120,000 - 180,000; Full time

Job summary

Boehringer Ingelheim is seeking a Senior Patient Safety Physician for Global Experimental Medicine Patient Safety, focusing on Eye Health investigational compounds in early development. The role offers strategic medical safety leadership and collaboration across global teams to shape safety strategy for first-in-human and proof-of-concept studies.

You will lead cross-functional development teams, review safety documentation, and communicate evolving safety profiles to leaders and regulators.

Qualifications

• Medical degree and ophthalmology board certification or international equivalent.
• Several years of combined clinical, academic, or pharmaceutical industry experience including patient safety physician work.
• Strong ability to evaluate and integrate complex clinical and translational data for benefit-risk assessments.

Responsibilities

• Lead proactive patient safety and benefit-risk strategy for exploratory ophthalmology compounds.
• Provide medical safety leadership for first-in-human and early studies, reviewing protocols and safety documentation.
• Integrate clinical, nonclinical, translational data to identify emerging safety risks and impact on development strategy.
• Define risk-management measures and contribute to governance, regulatory interactions and go/no-go decisions.
• Oversee ongoing safety surveillance, signal evaluation, and preparation of regulatory sections (DSURs, RMPs).
• Represent Safety in internal/external forums and support matrix teams on safety initiatives.

Skills

Medical expertise

Leadership

Cross-functional collaboration

Regulatory knowledge

Communication skills

Education

Medical degree (MD)

Ophthalmology board certification

Clinical development experience

Job description

The Position

Join Global Experimental Medicine Patient Safety as a Senior Patient Safety Physician and provide strategic medical safety leadership for Eye Health investigational compounds in early development.

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 opportunities 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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

This position offers the opportunity to shape safety strategy for first-in-human, proof-of-concept and other development studies, influence cross-functional governance and guide programs through complex medical and scientific decisions.

This position can be filled in different countries.

Tasks & responsibilities

• In your new role, you will lead proactive patient safety and benefit-risk strategy for assigned investigational compounds across early clinical development.

• You will provide medical safety leadership for first-in-human, dose-escalation, proof-of-concept and other clinical studies, including review of protocols, investigator brochures, safety monitoring plans and clinical study reports.

• Moreover, you will integrate clinical, nonclinical, translational, epidemiologic and external evidence to identify, characterize and communicate emerging safety risks and their implications for development strategy.

• You will partner with cross-functional development teams to define risk-management and risk-minimization measures and contribute to program governance, regulatory interactions and evidence-based go/no-go decisions.

• Furthermore, you will oversee ongoing safety surveillance, signal evaluation, aggregate safety assessment and medically sound input to regulatory documents, including DSURs, RMPs and submission safety sections.

• In addition, you will represent Experimental Medicine Patient Safety in internal and external forums, communicate the evolving safety profile to senior leaders and regulators, and lead matrix teams or strategic safety initiatives as assigned.

Requirements

• Medical degree (e.g. MD or international equivalent) from an accredited institution; a medical license (or equivalent registration) and board certification/ training in ophthalmology are strongly preferred.

• Several years of combined relevant experience in clinical practice, academic research or the pharmaceutical industry, including experience as a patient safety physician in the pharmaceutical industry. Experience in clinical development would be an asset.

• Strong medical and scientific expertise with the ability to evaluate and integrate complex clinical, nonclinical, and translational data to support benefit-risk assessments and strategic decision-making

• Solid understanding of global pharmacovigilance and clinical-development safety requirements, including safety surveillance, signal management, aggregate reporting and regulatory compliance in major markets

• Strong medical judgment and scientific analysis skills with the ability to evaluate and integrate complex clinical, nonclinical, and translational data to support benefit-risk assessments and strategic decision-making.

• Strong leadership skills, leadership presence, and communication skills, with the ability to collaborate closely with and influence cross-functional stakeholders in a global matrix environment.

• Demonstrated patient-focused mindset, high ethical standards, and strong accountability, with the ability to navigate ambiguity, take ownership, and drive outcomes effectively.

• Willingness to actively engage with global teams and attend key meetings in person as required.

As part of our commitment to transparency and fairness, salary information will be shared during the recruitment process. We also offer a comprehensive benefits and wellbeing package.

Applications from persons with severe disabilities are warmly welcomed. In cases of equal qualifications, such applicants will be given preferential consideration in the selection process.

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: [phone] or via mail: [e-mail]

JOB ID

37210

Job function

Medicine

Career level

Experienced professionals

Organization

BI Pharma GmbH&Co.KG

Working time

Flexible (Full-Time or Part-Time)

Job flexibility

Hybrid

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law