- Non-degree + 5 yrs safety experience*
- Associate degree + 4 yrs safety experience*
- Associate degree RN + 4 yrs safety experience*
- BS/BA + 3 yrs safety experience*
- MS/MA + 2 yrs relevant experience** (1-2 yrs safety experience)
- PharmD + 1 yrs relevant experience** (1 yr safety experience)
For PharmD, a one year residency of fellowship can be considered relevant experience.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
- Good verbal, written and presentation skills in Japanese and English
- Good communication.
- Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
- High degree of accuracy with attention to detail.
- Functions as a team player.
- Ability to present and share useful business information across departments and functions.
- Ability to anticipate and identify problems and take appropriate action to correct.
- Knowledge of medical and drug terminology
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Knowledge of ICH Guidelines
- Knowledge of Medical Device reporting desirable
- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
- Good knowledge and understanding of industry and R&D processes and objectives.
- Ability to work independently with minimal supervision
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
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