Position Summary

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:
  • Protocols
  • Investigator brochures
  • Safety summaries
  • Clinical study report
  • Regulatory reports (periodic, ad hoc)
  • Labeling changes
• 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

Knowledge, Ski8lls, Competencies, Education, and Experience

Required

Knowledge

• 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

Skills

• 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

Competencies

• 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%)
• Required to be in Princeton, NJ office 1 time per month and/or as required by business needs.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

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