PV Specialist - 製薬会社

お問合せ Hidetoshi Sato
JOB ID JO-2110-464728

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

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[Position] PV Specialist
[Location] 東京都/在宅勤務制度あり
[Salary] 7〜10 million JPY ※Experiences and skills will be considered
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[Company Description]
外資系製薬企業

  • 世界150 カ国で事業展開しているグローバルヘルスケア企業

  • 勤続年数の長い会社で5年以内に退職する方はほぼゼロで腰を据えて取り組める環境です

[Responsibilities]

  • This is a local PV role covering specific markets with strict regulatory requirements. The role is responsible for day to day local activities in line with required local vigilance regulations. Role responsibilities may include the following:

  • Prepares and delivers Pharmacovigilance training to all Country departments and relevant 3rd parties

  • Provides support and coordinate 3rd Party's due diligence for new local deals from medical perspective. To monitor its practice performance in PV management requirements on a regular basis.

  • Provides consultation and Human Safety Information/Adverse Event clause for contracts other than Safety Data Exchange agreement (SDEAs)

  • Provides integrated strategic safety expertise to local commercial programs and clinical development programme, etc.

  • Ensures Human Safety Information reporting compliance of Digital, Market

  • Research and Patient Support Program providers

  • Where relevant, regulatory reporting of aggregate and individual case summary report to local authority (if not covered by global service provider)

  • Maintaining up to date local product list and contact list

  • Support local literature searches as appropriate

  • Ensure English translations of all required safety documentation, including cases received directly from Central Safety functions

  • Relevant distribution and tracking of risk minimisation plans to markets

  • Ensures appropriate management monitoring of PV activities (including post-marketing and clinical studies) for Consumer Health Products

  • Provides support for Internal PV audits and external local Regulatory Authority inspections as needed

  • Support Regular GVP SOP update

  • Manage local post-marketing surveillance (PMS) activities for OTC products, and report the plan/results to Japanese HA (PMDA) when required

[Requirements]

  • Minimum 2 years experience in the field of Pharmacovigilance required (preferred 5yrs)

  • Healthcare or Pharmacy degree, pharmaceutics or life/biological sciences

  • Japanese / Japanese native level (N1) is a mandatory.

  • English / high level reading skill is a must, oral communication is weekly basis suh as global meetings

  • Good understanding of local regulatory environment and Knowledge of Pharmacovigilance, regulator and business requirements

  • Understanding of diversity of Consumer Health businesses and local regulations for cosmetics and devices

  • Proven ability to influence and negotiate with key internal and external stakeholders

  • Ability to deliver key process improvement initiatives

  • Excellent interpersonal communication skills and people management skills

  • Experience of internal and/or external audits and inspections

  • High degree of matrix working required, spanning several different business units.


Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Reference: JO-2110-464728
#LI-REMOTE
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance