- The Global Head of Medical Safety serves as the medical safety expert for all products in various stages of development and this includes preparing/conducting-Clinical Safety Reports, Safety Signaling, Health Authority Responses, Aggregate Reports, Risk management - RMPs and REMs, Labeling Changes, new drug filings, etc. She/he provides PV expertise to support strategic business activities and manages compliance with SOPs regulatory requirements relevant to patient safety, including safety reporting and risk management. Will deliver high quality safety information and knowledge to internal and external customers throughout the product life cycle. In addition, the Head of Global Safety interacts with senior business stakeholders, regulatory authorities and key opinion leaders - combining a high level of medical expertise with proficiency in PV and risk management, as well as strong and impactful leadership skills - influencing all phases of drug development.
- Leads Global Medical Safety, including:
- Reviews and determines medical safety needs and resource allocation for all projects.
- Leads staff and utilizes resources to ensure the delivery of high quality medical safety services.
- Designs, develops and implements new and innovative methods to improve the efficiency of the Global Medical Safety Department.
- Chairs the Medical Safety Review Team
- Serves as a liaison to regulatory agencies on safety issues.
- Serves as a technical advisor and provides guidance to Product Managers on GPV aspects of projects.
- Provides medical expert safety review and input to all critical documents for clinical development of products.
- Provides executive leadership for study teams when necessary to manage medical safety-related challenges and to achieve exemplary customer service.
- Ensures the improvement of the execution of all medical safety projects.
- Provides expert consultation to in-licensing activities and supports the due diligence research of select compounds and/or companies as requested.
- Takes ownership for initiatives within assigned unit of accountability, including development of measures for success.
- Supervises the Global Therapeutic Area leaders, Global PV.
- Collaborates with other functional area leaders, including Global Clinical Development, Global Medical Affairs, Global Regulatory Affairs, etc.
- Collaborates closely with Global Head of Pharmacovigilance, the regional heads in North America, Japan and Europe, and with the EU QPPV.
- Proven track record of innovation in Medical Safety strategy, implementation and execution.
- Proven strategic resource management experience (i.e. applying strategic planning, deployment and utilization of resources and technology to effectively fulfill the org/department's mission).
- Proven business and market knowledge (i.e. understanding stakeholder needs regarding business environments and developing strategies to maximize value to the organization.)
- Experience and knowledge of global development requirements in clinical safety and pharmacovigilance (US, Europe, Japan, China, Pacific Rim).
- In-depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Education and Related Experience:
- Strong leadership skills, including negotiation/influencing skills and effective presentation skills.
- Computer skills, including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Strong written and verbal communication skills, including good command of English.
- Excellent organizational and problem-solving skills.
- Effective time management skills and ability to manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Physical Demands and Work Environment
- Medical degree and board certification (preferred).
- Epidemiology experience and M.P.H. preferred.
- At least 10 years of experience working in Pharmacovigilance, with a minimum of 5 years of experience in a strategic leadership capacity.
- Must be considered a thought leader in Pharmacovigilance with established networks.
- Travel (approximately 20% to 40%).
- Occasional teleconferencing at "off business" hours, resulting from meetings held in US and Japan.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Valid Proof of COVID-19 Vaccination or Accommodation
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