This position will be responsible for the collection, documentation and processing immediately reportable events from clinical trials and all adverse events from post marketing spontaneous reports in accordance with Global Pharmacovigilance Regulations and the company's Standard Operating Procedure. Closely Monitor the safety profile of assigned products, both in development and post-marketing. Actively contributes to the preparation of aggregate and ad hoc safety reports. The position also includes but is not limited too:
Education and Related Experience
RN, LPN, or Pharmacist with 3 years or more of drug safety experience AND additional clinical or pharmaceutical experience
BS with 5 years or more of drug safety experience in the pharmaceutical industry
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.
OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.
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.