Global Clinical Safety Manager

Requisition ID 2023-12149
Posting Date 2 weeks ago(1/23/2023 8:56 AM)
Job Location(s)
Pittsburgh PA United States
Travel
10-20%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Clinical

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Global Clinical Safety Manager at Cook MyoSite, Inc. manages safety surveillance and ensures thorough product safety oversight across all Clinical Development programs. The Global Clinical Safety Manager leads the safety program to ensure thorough and effective monitoring, analysis, and reporting of safety information related to all clinical studies. This role is also responsible for ongoing development and execution of clinical risk management strategies, and actively collaborating with other team members and functions to advance long-range strategic plans for clinical and post-market safety programs. 

Responsibilities

• Responsible for active governance of GCP safety-related policies, procedures, operating guidelines, and ensuring their operational implementation.
• Implement adequate controls and procedures for review of unblinded data, where necessary, while maintaining integrity of blinded studies.
• Assist with compiling aggregate safety data for regulatory reporting (e.g. DSUR), as well as responses to safety related health authority requests.
• Review and approve required documentation for reporting potential serious risks, including Medwatch or CIOMS forms, Investigator Letters, or other applicable individual reporting requirements (e.g., associated device information).
• Ensure the accuracy and completeness of safety sections of applicable clinical documents (e.g., protocols, investigator brochures, procedure guidelines, study reports, informed consent forms, etc.).
• Ensure case evaluation is performed within the appropriate timelines to meet IND safety reporting requirements.
• Manage and maintain an electronic global safety database for tracking, storing, and reporting adverse events of all investigational and future marketed products.
• Oversee and ensure the thorough medical review (e.g. seriousness, relatedness, expectedness) of applicable individual case safety reports.
• Initiate and write queries to clarify information received from individual safety case reports or product complaints, where necessary.
• Obtain final evaluations and decisions regarding AE and safety information, including criteria for expedited reporting.
• Serve as Responsible Person and ensure appropriate registration and maintenance of information in EudraVigilance.
• Ensure integrity and quality of safety data including reconciliation of safety data listings is performed.
• Develop and maintain general safety surveillance and safety signal management methodologies.
• Work closely with medical advisors and coordinate meetings to evaluate safety information and ensure the rationale to support any changes to the safety profile of the assigned product(s) is documented.
• Assist in preparation of materials presented to Data Safety Monitoring Board.

• Be knowledgeable of product safety profile, including previously identified and observed risks.
• Provide functional support and input to establish and manage vendor relationships (e.g., contract agreements, vendor oversight, risk and safety management plans).
• Oversee team members and support personnel development to ensure essential job functions and duties are performed at high standards.

Qualifications

• Undergraduate degree in Pharmacy, Nursing, Epidemiology, Immunology, or health care related disciple and 5 years direct, relevant experience in drug safety and/or clinical research and safety experience in the biotech/pharmaceutical industry

• Graduate degree in Pharmacy, Nursing, Epidemiology, Immunology, or health care related disciple preferred
• MD, PharmD, PhD, MPH, or NP preferred

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook

• Demonstrates strong interpersonal skills resulting in exceptional rapport with people. Proven success initiating, promoting and maintaining strong interpersonal relations
• Is a teacher and trusted leader

• Proactively and appropriately challenges the status quo and champions change for the advancement of the organization
• Is a positive influence within the company and supports it, and their colleagues, both publicly and privately

• Ability to present complex information in a clear and comprehensive manner
• Is an effective communicator with internal and external stakeholders. Conveys clear expectations, actively listens to input and responds to feedback appropriately and in a timely manner

 

Physical Requirements:
• Remote/Field Based Setting: Full time Remote position | General office or home office setting

• Travel (Domestic & International): 10-20%

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
• Must be (a) physically capable of operating a motor vehicle on a regular basis, (b) a holder of a valid driver's license, and (c) in good standing to legally operate a motor vehicle.
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations.

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