For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Job Description
The Medical Information Specialist (MIS) is part of the ProPharma MI Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints. Responds to unsolicited consumer, health care professional, and other external customer requests for medical and safety information received via the contact center, and website/e-mail.
Essential Functions:
1. Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards, and client and ProPharma Group internal policies and practices.
2. Proficient in medical terminology both in English and Japanese, verbally and in writing.
3. Accurately identifies, documents, and reports adverse events, pregnancy reports, special situation events, and product complaints in a clear and concise manner within required timeframes according to government regulations, ProPharma Group internal SOPs, and client working practices/instructions.
4. Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature, and other data (e.g. internal clinical data, post-marketing surveillance data). Assists with writing custom responses utilizing this data.
5. Adheres to company and country-specific privacy policies.
6. English speaking/writing desirable.
Necessary Skills and Abilities
1. Excellent Japanese language skills, verbal and written.
2. Ability to write fluent and grammatically correct native (primary) language.
3. Working knowledge of medical terminology, pathophysiology, pharmacology, regulations, and industry standards in Japanese language
4. Ability to correctly identify question(s) and formulate and communicate an accurate response utilizing multiple resources of information which may require scientific interpretation.
5. Excellent interpersonal skills including empathetic customer service skills.
6. Receptive to constructive feedback.
7. Self-motivated. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload or projects.
8. Aptitude to learn other computer systems including inquiry handling database.
Educational Requirements:
1. Professional healthcare degree with active licensure.
2. Pharmacist preferred
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
Additional Job Description
医療情報スペシャリスト（MIS）は、プロファーマグループ医療情報コンタクトセンターの一員として、全ての関連する規制、業界標準、クライアント/当社ポリシーに従いながら、医療情報の提供や、副作用報告、特別状況事象、製品苦情の収集と文書化を行います。コンタクトセンター、ウェブサイトやEメールから受領する医学情報および安全性情報の問い合わせに関して、様々な顧客、医療従事者ならびにその他外部の顧客に対応します。
必要とされる能力
• 規制要件、業界標準やプロファーマグループの社内方針や行動基準を順守し、承認、非承認の医学/安全性情報を提供すること。
• 口語力、文筆力において英語、日本語での医学専門用語に堪能であること。
• 有害事象、妊娠等への投与報告、特別状況下での事象、製品苦情を明確かつ簡潔に、求められる時間内に政府規制、プロファーマグループの社内SOP、クライアント様の業務手順書/指示に従って、正確に認識し記録、報告すること。
• 承認された添付文書、会社の標準回答書、公表文献やその他データ（例：社内臨床データ、製造販売後調査データ）を活用して、正確な回答を作成し提供すること。これらのデータを活用して、顧客への回答文書を作成すること。
• 会社と国特有の個人情報保護方針を順守すること。
• 英語の口語力、文筆力があることが望ましい。
必要とされる技能
• 優れた日本語の口語力と文筆力
• 流暢かつ文法的に正しい日本語の文章作成能力
• 医学用語、病態生理学、薬理学、規制および業界標準の日本語での実務知識
• 質問を正しく理解し、科学的解釈を必要とする複数の情報資源を利用して、正確な回答を作成し、提供する能力
• 親身になって顧客に情報提供する能力を含む優れた対人能力
• 建設的な意見を受け入れる能力
• 自発的能力。自発的にかつ自ら意欲的に業務を推進する能力。より多くの仕事やプロジェクトを追求する意欲。
必要資格
• 有効な資格を伴う医療関連学位を有すること
• 薬剤師が望ましい
必要経験
• 最低１～３年の医療実務または規制環境での勤務経験を有すること
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***