Summit Therapeutics

Director, Safety Physician

Remote (US) · Director

Sponsorship not specified$10k-$20kDetected 29 days ago

Data AnalysisProcess ImprovementRecruitingICD-10Clinical TrialsPharmacovigilanceCommunicationCollaborationProblem SolvingCritical Thinking

About the role

Reporting to the VP of Patient Safety & Pharmacovigilance (PSPV), the Safety Physician Director will be responsible for investigational and marketed product pharmacovigilance activities.

Act as product lead and/or therapeutic area lead as assigned.
Implement appropriate case follow up / queries per SOPs.
Support reconciliation between Safety and Clinical databases.
Develop, maintain, update, review and approve list of expected terms via the Reference Safety Information (RSI) in the IB, in collaboration with development partner and cross-functional teams.
Author, review and/or approve safety content of various aggregate safety summary documents such as DSURs, PBRERs, Regulatory Response documents, Safety Signal Evaluation documents, etc., when requested.
Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor.

Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

MD/DO or international equivalent plus a minimum of 8+ years relevant work as a safety physician.
Working knowledge of case management and medical review processes and procedures.
Proficiency in technical safety systems.
Experience in safety data analysis and writing study related narratives, aggregate reports and safety assessments.
Experience in MedDRA coding and search strategies.
Strong computer and database skills.
Attention to detail, accuracy and confidentiality.
Clear and concise oral and written communication skills.
Excellent organizational, critical thinking, and problem-solving skills.
Communicate effectively and articulate complex ideas in an easily understandable way.
Prioritize conflicting demands.
Work in a fast-paced, demanding and collaborative environment.

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
This may be different in other locations due to differences in the cost of labor.
The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports.
Evaluate medical accuracy of ICSRs reports.
Interact and liaise with PV vendor medical reviewer and Summit Medical Monitors.
Share ICSR case quality issues with PV Operations as appropriate, and support Quality Assurance of ICSR medical review.
Develop and support medical coding conventions, and systematic process improvements for ICSR medical review.
Act as a Medical Safety Review process lead and support the development, training on and implementation of new processes in Medical Safety Review.
Mentor junior medical safety reviewers as needed and applicable, provide direct managerial responsibilities for medical safety reviewers on therapeutic or functional team.
Maintain a state of inspection readiness, and act as functional representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
Experience, Education and Specialized Knowledge and
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.

At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality.
Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.

This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.