- Supports safety teams in all aspects of pharmacovigilance and risk management activities for assigned products, both marketed and in development (phase I to IV).
- Key activities include medical analysis and decision making for the development and maintenance of the Company Core Data Sheet, ad hoc and periodic aggregate safety reports, , ,risk management plan (RMPs/REMS), signal detection activities and health authority filing/submission/responses.
- 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 issues relevant to his/her assigned products.
- Proactive Monitoring of product safety profile from FIH throughout lifecycle through partnership with GCD Project Leaders on Program Development from Phase I to LCM regarding safety and risk-benefit topics and decisions
- Performs signaling activities including review of medical/scientific literature, and contribute to safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
- Leadership and ownership of internal safety governance bodies (SMT, JSMT).
- Active contribution to internal and external forums (e.g., DMC, Advisory Boards)
- Timely escalation of safety issues to safety governance forums
- Reviews aggregate safety data to provide medical input into aggregate safety reports such as PBRER, DSUR, PSUR, PADER as well as ad hoc queries or reports for submission to regulatory agencies in a global environment
- Develops and implement Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS)
- Contribution and review of safety documents from individual patient data to submission-level safety documents
- Contribute to label development, scientific regulatory responses.Review and Approve Coding.
- Supports global clinical development, medical affairs, data sciences and regulatory activities as the pharmacovigilance representative
- Contributes to oversight and provides guidance to medical review of individual case safety reports (ICSRs) for investigational and marketed products.
- Contributes to scientific and medical publications, posters and presentations as needed
- Attends internal or external audits and regulatory inspections to represent pharmacovigilance when assigned. Ensures and sustains inspection readiness
- Contributes to the development and authoring of Standard Operating Procedures, Work Practices, Job Aids and other guidance documents
- Provide medical and PV oversight and key input to:
- Investigator brochures
- Safety summaries
- Clinical study reports
- Regulatory reports (periodic, ad hoc)
- 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.
- Oncology, Neurology or Cardiorenal 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
- MD degree with US medical license (preferred)
- Demonstrated experience (at least 2-5 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.
- Travel (approximately 10-25%)
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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