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 Director Risk 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 company's products.
Ensure that the benefit-risk assessment is current and that any changes are as per governance principles.
Ensure patient safety for company's 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 OR
Bachelor's 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.
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.
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