Daijob.com is Japan's definitive job site for multilingual professionals.

日本語

HOME
Search

Advertise your job with us!

Tokyo

2024.5.24 [Fri.]

Akihabara UDX 2F AKIBA_SQUARE

Job Search

Updated 2024-04-08
Activated 2024-04-08

Drug Safety Manager - EU Pharma

Recruiter
Staff Level

This posting is managed by:	Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Company Name	Company is not publicly visible
Job Type	Medical/Pharmaceutical/Bio/Fabric/Food - Clinical R & D
Industry	Pharmaceuticals
Location	Asia Japan Tokyo
Job Description	* Manage case processing activities and safety risk management for both investigational and marketed products, ensuring compliance with internal procedures and regulations Description * Manager of pharmacovigilance system in Japan including partnerships * Ensure full compliance with applicable pharmacovigilance regulations in Japan and with internal requirements Responsible * Support Clinical team for CTD submission and clinical trial management from a safety point of views as needs * Support to inspection and audit readiness of the affiliates in Japan in full collaboration with Patient Safety and pharmacovigilance QA * Evaluate ICRSs, literature, regulatory intelligence in foreign countries, and report to the local authority according to local regulations * Report all adverse event/reaction report (spontaneous Health Authorities, literature, etc.), to Global Patient Safety in timely manner * Evaluate the reportability and submit all qualifying case report and any new information relevant to the evaluation of the benefit/risk afforded by a product as required by local regulations and Global Patient Safety procedures Profile * Bachelor's degree, 3+ years of pharmacovigilance experience, knowledge of PV regulations and non-interventional studies, proficiency in English, and strong skills in safety information evaluation and collaboration. Job Offer * Work in an organization that values work/life balance, flexibility and career development * International career development possibilities in Japan and overseas Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info	* European bio-pharmaceutical company, with rich development pipeline in immunology, oncology and neurology areas * Our client is a leading player in the pharmaceutical industry, renowned for its commitment to innovation and patient care. With a global presence and a rich legacy of breakthroughs in healthcare, they offer an unparalleled opportunity for professionals seeking to make a real difference in people's lives. * At this dynamic organization, you'll be part of a team dedicated to advancing medical science and improving patient outcomes. From managing case processing activities to conducting safety risk management for cutting-edge compounds, every role here contributes to the development of life-changing therapies. * Joining our client means joining a culture of excellence and collaboration. You'll have the chance to work alongside industry experts, participate in high-level trainings, and contribute to the shaping of regulatory standards in pharmacovigilance. * Moreover, our client values talent and fosters a supportive environment for growth and development. Whether you're an experienced professional or just starting your career in pharmacovigilance, this is the place where your skills will be recognized, your ideas will be valued, and your career will thrive. * If you're passionate about making a meaningful impact in healthcare and seeking a stimulating and rewarding career opportunity, our client is the perfect place for you to grow and succeed.
Working Hours	Monday - Friday 09:00 - 18:00
English Level	Business Conversation Level (TOEIC 735-860)
Japanese Level	Fluent(JLPT Level 1 or N1)
Salary	JPY - Japanese Yen JPY 9000K - JPY 13000K

Apply

Like Print

Back

People who viewed this job offer also looked into these.

Additional listings by this company

Japan's No1 job site for multilinguals・Job Details 「Daijob.com]　TOP

You will now be redirected to an external site.
Please confirm each site’s terms of agreement (privacy policy) in regards to the management of personal information.

Agree and Redirect