PV Specialist
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MAIN FOCUS AND MISSION:
Based on the Safety Specification identified during drug development phase, we develop the drug Risk Management Plan (RMP) and conduct Individual Case Safety Report (ICSR) processing, in accordance with the relevant laws and regulations.
In addition, to execute these plans and operations, optimizing the process in collaboration with vendors and other stakeholders is a key success factor. This plays a vital role in drug fostering, aiming to maximize the value of our products.
Principal Responsibilities:
The following Drug Safety related activities will be performed based on previous experience and career ladder:
1.Preparation and revision of drug Risk Management Plans:
●Investigation of the drug development information and competitive product information
●Description related to Safety Specification, Pharmacovigilance activities and Risk minimization activities in Risk Management Plan.
●Interaction with regulatory authorities (e.g., PMDA) concerning RMP and other RMP related matters (including response to inquiries, etc.)
●Maintenance for Risk Management Plans in collaboration with internal and external stakeholders (Global Safety, R&D, PMS, Medical etc.) as the lead for RMP preparation.
2.EPPV and ICSR Processing:
●Planning and conducting EPPV in collaboration with the Pharmacovigilance operational department (Sales department).
●Conducting ICSR processing with domestic CRO/vendor management, in collaboration with Global safety-ICSR, Global safety-tool teams etc.
●Troubleshooting for ICSR processing in Argus/J.
3.Preparation and management of periodic safety reports and reexamination / reevaluation application dossier:
●Writing, submission and application of periodic safety reports (e.g., DSUR, PSUR, Periodic Report for Non-Serious Unlisted Adverse Drug Reactions etc.) and reexamination application dossier (Drug Safety related part), including tracking the progress of these activities.
●Communication with regulatory authorities (e.g., PMDA) concerning periodic safety reports and reexamination applications (including response to inquiries, etc.)
4.Drafting and implementation of safety assurance measures.
5.Drug Safety related documents review:
●Review of CTD for new drug application (Drug Safety-related documents).
●Materials for ensuring proper use.
6.Response to Inspection:
●Responding to inspections and audits by domestic and overseas regulatory authorities and internal departments.
YOUR PROFILE:
Required Qualifications:
●University/Graduate School of Medicine, Pharmaceutical Sciences or Natural Sciences with a specialty/master's degree. Medical qualifications are preferable.
●Native Japanese, and Business level fluency in English.
●Able to give presentations and exchange e-mails in English.
●Excellent reading comprehension of English documents (e.g., Common Technical Documents etc.) in medical and pharmaceutical sciences. 750 or above in TOEIC L/R.
Job Experience:
●Minimum 5 years of work experience in pharmacovigilance for drug in development or post marketing.
●Experienced personnel in charge of product PV risk management with other departments, partners, HQs, CROs and/or regulatory authorities.
●Experienced personnel in charge of ICSR in pharmaceutical companies or CROs.
●Experienced in preparing various periodic reports (e.g., DSUR, J-PSUR, Periodic Report for Non-
Serious Unlisted Adverse Drug Reactions etc.)
●Experienced in preparing risk management plans.
●Experience in the oncology field (preferred).
Skills/Knowledge Required:
●Knowledge of medical and pharmaceutical sciences, related regulations and various guidelines (The PMD Act (formerly the Pharmaceutical Affairs Law), GVP, GPSP, GCP, Clinical Research Act etc.) Knowledge of GxP is mandatory.
●Basic knowledge of oncology and anti-cancer drugs
●Skills: business communication, regulatory affairs document preparation and review, general PC skills (Microsoft Office 365, Word, Excel, PowerPoint, SharePoint site, etc.), Project Management.
Servier Leadership Model:
●Collaborate and play as a team (Be a team player and keep the Group interest first. Allow decision at the right level (subsidiarity).
●Take ownership (Take initiatives and celebrate success).
●Engage for performance (Be solution oriented).
Soft skills:
●Able to flexibly grasp and adapt to changes in the external environment without being constrained by existing frameworks.
●Able to take the initiative in carrying out tasks on their own.
●A person who is not afraid of working according to various procedures, version control of materials, and other meticulous work.
Career advancement:
●Expansion of responsibilities, or enhancement of expertise in RMP planning and ICSR operation, or medical writing-related tasks, etc.
●Training of subordinates and junior staff. Promotion to the position of Group manager.
Other Relevant Information:
●Basically, office work at the Head office (Tokyo Otemachi-office) or WFH.
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.