Acelity Careers

Director, Global Safety

San Antonio, United States of America
Medical Affairs JFG


Job Description

Dir Global Clinical Safety

Description

 Position Summary:

The Director of Global Clinical Safety conducts all assigned and necessary activities during the product development through the lifecycle of the product, to integrate safety related measures in all applicable processes, with the aim of the safety of the patients and care givers who use KCI products.

Primary Duties/Responsibilities:

·         Establish & maintain safety programs to support developmental products

·         Provide early, hands-on operational support to teams in clinical trial planning, protocol development, training of internal and external personnel, medical monitoring for trial safety, and quality control

·         Develop policies for interaction with independent study safety boards; ensures exchange of information with these committees is adequate to meet study timelines

·         Contribute to effective global post-marketing surveillance of KCI marketed products

·         Review, edit and approve adverse event narratives to ensure medical accuracy

·         Contribute to effective reporting and follow-up of any adverse events for KCI products, in conjunction with the regulatory compliance and clinical development departments

·         Assess safety profile of KCI products under development

·         Identify labelling issues and provide safety expertise to labelling process

·         Represent the Global Safety department in internal and external audits

·         Conduct thorough product safety evaluation during in-licensing/acquisition projects

·         Contribute to the company's safety philosophy and oversee integration with Research and Development (R&D), Regulatory, Clinical Research, Commercial, and Quality functions

·         Ensure that sound safety standards are maintained or expanded and that the function contributes to the strategic goals of the business

·         Evaluate current safety systems, processes and functions and recommend/implement measures to ascertain their effectiveness

·         Maintain an awareness of risk management within the company including activities to support proactive risk assessment, safety signal detection and risk minimization for marketed products and development programs

·         Provide leadership for the safety staff including goal setting, performance reviews, staff development

·         Manage the global safety department budget

·         Determine the optimal organization structure to meet current programs and product objectives and effectively assign staff to support key activities and roles

·         Maintain knowledge of current and latest developments in wound healing research and other areas related to KCI products and pipeline

·         Liaise with multiple internal functions, particularly R&D, Clinical Development, Regulatory, Quality and colleagues in the Medical Affairs Department

Qualifications

Position Qualification Requirements:

Basic Qualifications:

·         Medical or nursing degree

·         At least 5 years experience in providing safety and pharmaco vigilance support within the pharmaceutical/medical device industry

·         Experience with MS Office applications including:  Word, Excel, & Outlook

Other Position Qualifications:

In addition to the basic qualifications listed above, the following other position qualifications are required:

·         Experience establishing and maintaining safety programs to support developmental products

·         Experience providing operational support to teams in clinical trial planning, protocol development, training of internal and external personnel, medical monitoring for trial safety, and quality control

·         Experience developing policies for interaction with independent study safety boards

·         Experience reviewing, editing, and approving adverse event narratives to ensure medical accuracy

·         Experience with safety handling during PMA/IDE processes

·         Experience with safety handling during clinical trials

·         Experience in supervising drug/device safety personnel, budgeting, organizing, and planning for a growing safety department

·         Working knowledge of regulations related to safety and risk management, including ISO, CFR, CIOMS, ICH, GCP, MedDev

·         Demonstrated ability to operate effectively and achieve results in a dynamic, matrix organization as part of a working team environment, with the ability  to provide both strategic leadership on safety issues and tactical input

·         Thorough knowledge of United States and European safety reporting regulations and guidelines

·         Excellent oral and written communication skills

·         Excellent coaching and mentoring skills

·         Must be able to travel by commercial airline as required

·         Must be able to work overtime as deemed necessary by business objectives

Preferred Qualifications:

In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:

·         Experience as a director of safety in medical device or pharmaceutical environment

·         Experience with safety regulations and the related IRB and Ethics committee and other regulatory submissions

·         Experience with wound healing and other clinical aspects related to KCI products

The information listed in this Job Description is not a comprehensive list of all duties/responsibilities performed.

This Job Description is not an employment agreement or contract.  Management has the exclusive right to alter this position guide at any time without notice.

The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor