Job Description - 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: - Protocols - Investigator brochures - Safety summaries - Clinical study reports - Regulatory reports (periodic, ad hoc) 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. - 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%)
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.
Statement Regarding Job Recruiting Fraud Scams
Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
Internal Number: R106
About Otsuka Pharmaceuticals
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.