Director, Safety Physician
Leads product safety teams in all aspects of pharmacovigilance and risk management activities for assigned products both marketed and in development. Key activities include medical analysis and decision making for the development and maintenance of the Company Core Data Sheet, ad hoc aggregate safety reports, periodic safety update reports (PSURs), signal detection activities and risk management plan (RMPs/REMS) and individual case safety reports. He/she will work in cross-functional teams with counterparts in regulatory, clinical development, pre-clinical, manufacturing/quality, global pharmacovigilance and other functional areas to identify, evaluate and communicate safety observations relevant to his/her assigned products.
Key Job Responsibilities
Analysis of comprehensive product information, synthesis risk-benefit assessment and reporting
Proactive monitoring of product safety profile from first in human throughout lifecycle
Primary ownership and accountability for product signaling review analysis delivery and approval
Timely action and communication of findings in safety governance forums
Leadership and ownership of internal safety governance bodies (Safety Management Team, Joint Safety Management Team) Active contribution to internal and external forums (e g., Data Monitoring Committee, Advisory Boards)
Contribution and review of safety documents from individual patient data to submission-level safety documents
Partnership with Global Clinical Development Project Leaders on Program Development from Phase I to life cycle regarding safety and risk- benefit topics and decisions including contribution and review of new drug approval filing documents
Contribute to label development scientific regulatory responses
Review and approve event coding
Active, regular utilization of data review, reporting and visualization tools & systems
Provide medical and PV oversight and key input to:
Clinical study report
Regulatory reports (periodic, ad hoc)
Train drug safety associates and contribute to mentoring and on-boarding of new colleagues
Serve as the subject matter expert from a safety perspective
Work extensively with colleagues from across the globe
Participate in department decision making and strategy
Ensure all activities are of the highest safety and ethical standards
Required Knowledge, Ski8lls, Competencies, Education, and Experience
Requires a strong medical background evidenced by clinical training
Solid knowledge of FDA and global PV regulations.
Knowledge of clinical trials, good clinical practices, and ICH guidelines
Immunology and Oncology or Neurology experience a plus
Experience in working in a global setting
Experience with industry software and databases
Sound computer skills and be well versed in the use of Microsoft Office
Excellent verbal and written communication skills
Good presentation skills
Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous high priority tasks
Strong leadership skills
Ability to adapt to a dynamic work environment
Education and Related Experience
Medical Doctor degree with US medical license (preferred)
Demonstrated experience (at least 5-7 years) as a Safety/PV professional in a pharmaceutical industry
Experience with both development and product launch/post marketed products preferred
Ability to act as in-house authority/leader in Safety and Pharmacovigilance, and be fully accountable for Safety of assigned products
Experience interacting with global regulatory authorities
Physical Demands and Work Environment
Travel (approximately 10%)
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
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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