Job Description

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.


Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Position Title:

Manager, Medical Safety

Position Type:

Permanent, Full-time, Remote

Reports to

: VP Global Safety Vigilance

Pay Range:

70k - 90k

Purpose:

The incumbent is responsible for overseeing medical safety for clinical trials (Phase I-IV) globally. The role focuses on identifying, evaluating, and managing safety risks throughout the clinical development process, ensuring compliance with regulatory requirements and company safety standards. The incumbent will provide an unbiased medical, scientific and therapeutic expertise.

Key Responsibilities:

Review clinical protocols and provide input on safety evaluation


Develop and implement Safety Monitoring Plans for clinical trials (Phase I-IV)


Review safety sections of the ICF


Provide safety-related input to other study documents and processes, as needed


Review and evaluate masked clinical data and adverse event reports from clinical trials, laboratory results, and other safety-related information to identify safety signals


Identify potential safety risks in clinical trials and develop risk minimization measures to address identified safety concerns


Identify and investigate safety signals that emerge from adverse event reports and relevant literature


Prepare safety-related communications for investigators, ethics committees and regulatory authorities


Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements


Participate in safety review committees, data monitoring committees, Clinical Trial Safety Data Review meetings and other meetings as directed by the charter/manager


Provide medical expertise for safety updates and submissions


Contribute to the preparation of blinded safety-related regulatory documents/dossiers (e.g., CTD section 2.7.4) including but not limited to Investigator's Brochures and Development Safety Update Reports (DSURs)


Ensure compliance with global safety regulations and guidelines, including ICH, FDA and EMA requirements


Complete other medical and safety tasks (i.e., providing input to medical/safety protocol deviations, responses to medical/safety questions raised by Ethics Committees or Health Authorities or medical review of coding of adverse events in a trial)


Support global pharmacovigilance and other department audits and inspections when required related to medical safety


Create and maintain controlled medical safety documents (e.g., SOPs)


Perform other medical safety related activities as assigned

Qualification:

Education:


Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to Ophthalmology preferred.


Direct patient care experience preferable


Experience:


A minimum of 3 years in medical safety/clinical


At least 3 years of relevant clinical trial experience


Skills:


Knowledge of GCP (Good Clinical Practice) and other clinical trial regulations, knowledge of global pharmacovigilance regulations


Excellent command over English language (written and verbal)


Strong analytical and critical thinking skills


Excellent communication and interpersonal skills


Ability to manage multiple tasks/projects simultaneously


Must be available during USA time zone working hours


The masculine is used in this publication without prejudice for the sake of conciseness.


Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.


We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. Accommodations for job applicants with disabilities are available on request.