26 days old

[JDSU] Staff, Product Safety /

Pfizer
Tokyo
/ Description of Primary Role & Responsibility

1.

2. MHLWPMDA

3.

4. JMT/ JVT

5. J-RMP

6. GPSPGCPAudit

7.



1. Develop local aggregate reports (J-PSUR, J-DSUR, NUPR, J-Infection report, etc.) and re-examination application report

2. Develop regulatory query responses and regulatory safety commitment reports other than above

3. Monitor domestic/foreign safety information of marketed/investigational products and propose safety measures

4. Contribute to development of investigational products as JMT/JVT members

5. Lead development/revision of J-RMPs, and manage them properly

6. Prepare and respond for inspection (GVP/GPSP/GCP inspection, Company internal audit)

7. Participate in projects related to building of business processes including global organization







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+ TOEIC 730

+

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+ PCWord/Excel/Power Point





Desired Behavioral and Technical Skills



+ Basic regulatory/medical knowledge related to pharmacovigilance

+ English skills including writing/speaking/listening (TOEIC score : >=730 or equivalent)

+ High sense and enthusiasm for pharmacovigilance

+ Cooperativeness (team work) and leadership (ownership)

+ PC skills (Word/Excel/Power Point)









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+

+

+





Desired Experiences



+ Medical qualifications such as pharmacists, or science background

+ Pharmacovigilance or equivalent experience preferred

+ Experience handling safety data preferred

+ Participation in global project preferred





Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical

Categories

Posted: 2020-10-01 Expires: 2020-10-31

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[JDSU] Staff, Product Safety /

Pfizer
Tokyo

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