※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] PV Specialist
[Salary] 7〜10 million JPY ※Experiences and skills will be considered
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
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.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance