Medical Safety Review Physician, Associate Principal Scientist Full-time

Individual Case Medical Review (ICMR) Physician

As an Individual Case Medical Review (ICMR) Physician, you apply your clinical expertise to ensure patient safety and high-quality medical assessments. You work in close collaboration with global medical and safety experts, contributing to informed safety and risk-management decisions.

What you will do:

Under the guidance of experienced medical leaders, you review and medically assess individual patient safety cases from a wide range of sources.

Your main responsibilities include:

• Performing medical review of individual safety cases in line with established procedures
• Assessing cases based on available safety data and known product safety profiles
• Determining whether cases require expedited reporting to health authorities
• Ensuring accurate, high-quality case documentation, including medical assessments and causality evaluations
• Supporting timely reporting by meeting global safety timelines
• Collaborating with clinical safety and risk management colleagues on complex cases
• Contributing to quality reviews, training activities, cross-functional projects, and process improvements within the team

What skills you will need:

To be successful in this role, you bring the following qualifications and skills:

• Medical Doctor or equivalent non-US degree in Medicine
• At least one year of post-training clinical experience with direct patient care (three years preferred)
• A minimum of three years of relevant professional experience post-training, which may include clinical practice and/or pharmaceutical industry experience
• Strong understanding of medical and scientific concepts
• Excellent written and verbal communication skills in English
• Effective presentation skills and experience influencing and collaborating with stakeholders
• Solid computer skills, including use of databases and standard office applications
• Strong analytical thinking, problem-solving ability, and sound clinical judgment

Ideally, you bring some of the following experience:

• Medical specialization or prior experience in drug safety, pharmacovigilance, or risk management
• Experience with medical case review, case management, or related safety activities
• Familiarity with drug development processes and/or regulatory or safety environments
• Experience working with safety databases or related systems (e.g. Argus, ARIS-G)
• Experience collaborating in international, cross-functional teams

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

Required Skills: Accountability, Adaptability, Audit Process Evaluations, Business Administration, Case Writing, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Risk Management, Clinical Sciences, Clinical Trials, Compliance Program Development, Continuous Process Improvement, Critical Thinking, Data Analysis, Decision Making, Detail-Oriented, Drug Safety Surveillance, Ethical Compliance, Healthcare Risk Management, Innovation, Machine Learning (ML), Medical Writing, Pharmacovigilance

Preferred Skills: