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Job Title: Director, Safety Physician
Location: Princeton, NJ United States
Position Type: Full Time
Post Date: 12/09/2022
Expire Date: 02/09/2023
Job Categories: Biotechnology and Pharmaceutical
Job Description
Director, Safety Physician
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:
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

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;


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

The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at:, or your local authorities.
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