Global Safety Lead, Senior Safety Physician

Overview

SUMMARY OF KEY RESPONSIBILITIES
• Provide strategic medical safety leadership and practical contributions for the Company’s assigned product(s) in a cross-functional setting.
• Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad hoc aggregate safety data reviews, as needed for the Company’s assigned product(s).
• Lead cross-functional team to perform regular and/or ad hoc review of existing and emerging aggregate safety data for the Company’s assigned product(s).
• Contribute to the development of the overall safety governance structure and activities.
• Provide safety strategies and deliver accurate, timely, and high-quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g., ISS, SCS, narratives) for the Company’s assigned product(s).
• Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, ICFs).
• Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate.
• Lead the overall preparation of periodic safety reports (e.g., PSUR, DSUR), providing medical safety content and ensuring consistency and quality of such documents.
• Oversee the medical assessment of individual Case Safety Reports (ICSR).
• Confirm criteria and content for expedited reporting and unblinding (e.g., SUSAR or urgent safety issues).
• Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB).
• Provide medical safety contributions at internal audits and regulatory inspections.
• Support the development of, and updates to, GPS Standard Operating Procedures (SOPs), and other controlled documents (e.g., work instructions, forms, templates).
• Support adverse event reporting training and pharmacovigilance awareness activities cross-functionally.
• Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners.
• Participate in cross-functional teams and initiatives.
• Perform other tasks as required to assist in department activities.

REQUIRED QUALIFICATIONS AND SKILLS
• MD degree, or equivalent required.
• At least 7 years’ relevant experience in the pharmaceutical/biotech industry, with at least 5 years in pharmacovigilance/drug safety. Global experience is a plus.
• At least 1 year of experience in clinical practice or in academic medicine.
• Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents.
• Demonstrated ability to perform medical assessments of safety data from multiple sources.
• Experience with authoring complex documents and contributing to regulatory submissions.
• Knowledge of adverse event reporting systems.
• Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus.
• Strong scientific and analytic skills.
• Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams.

 

No. of Vacancies
1
Job Nature
Full-time
Experience Requirements
7
Job Location
North Carolina, US
Job Level
Sr. Position

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