- 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
- 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
- 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
- Travel (approximately 10%)
- Required to be in Princeton, NJ office 1 time per month and/or as required by business needs.
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Director, Global Medical Safety, Global Pharmacovigilance - Princeton, United States - Otsuka Pharmaceutical Co., Ltd.
Description
Position SummaryLeads 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
Required
Knowledge
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.
Come discover more about Otsuka and our benefit offerings;
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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.
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 https://vhr-
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: 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.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and ODH, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
