Scientific function responsible to support a global pharmacovigilance system (both development and post marketing). Scientific functions includes but not limited to signal detection, risk assessment and management, Risk Management Plan (RMP) development, aggregate safety reporting, and clinical safety surveillance.
The Associate DirectorRisk Evaluation and Reporting will be responsible for co-leading and participating in pharmacovigilance activities under the direction of the Director of Risk Evaluation and Reporting. The Associate Director Risk Evaluation and Reporting will function in compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure proper benefit-risk assessment and patient safety for companys products.
Ensure that the benefit-risk assessment is current and that any changes are as per governance principles.
Ensure patient safety for companys products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe
Timely completion of PV Assessment activities through product development, product maintenance and lifecycle management.
Represent all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and report back relevant information regarding status, issues, and/or challenges
Serve as a safety scientist on the medical safety team and participate in signal detection, risk management, mitigation plans, and safety analyses for aggregate reports and Health Authority responses.
Collaborate with key Otsuka stakeholders for content and delivery.
Participate in training sessions, workshops, and/or conferences, and share knowledge with team members, as agreed.
Participate, implement, and/or co-lead process improvement activities in regards to utilization of routine data output review, reporting and visualization tools/systems that support medical safety activities.
Ensure compliance management, as needed, with maintenance of SOPs within the scope of medical safety activities
Report to the Director of Risk Evaluation and Reporting
Excellent communication and interpersonal skills and experience in mentoring others
Demonstrated qualities of competency, accountability, initiative, and leadership
Experience in process improvement initiatives
Extensive knowledge of US, ICH and EU PV and GCP regulations
Experience with Risk Management and Signal Detection preferred
Excellent strategic decision-making and analytical skills
Strong leadership skills with excellent track record
Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint
Strong verbal, writing and organizational skills, including a good command of English
Experience with Regulatory Authority Inspections (PV and GCP); experience managing vendors
Medical writing experience
Education and Related Experience
Graduate degree in health sciences, nursing, pharmacy, public health, epidemiology or other relevant health-related field (MD, PhD, PharmD, NP, PA, pharmacy or nursing degree) with at least 4 years of experience in clinical, pharmacological, or related fields of expertise
Bachelors degree in health sciences, nursing, pharmacy, public health, epidemiology or other relevant health-related field plus 10+ years of relevant experience in drug safety/pharmacovigilance, or related fields in the pharmaceutical industry.
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide. Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a big venture company at heart, applying creativity in everything it does. Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion ( 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en . Learn more about Otsuka in the U.S. at www.otsuka-us.com .
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.
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.
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Primary references are publications that are cited as references during examination development.