Job Description
企業概要
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
求人内容
Responsibilities:
Oversight of the Pharmacovigilance System Collaborating with the GPS regional teams, along with the ASR, ensures that PV processes, procedures and systems are in place to comply with AbbVie Global PV procedures and with local and/or regional PV regulations.
Quality Management System
Collaborate with the GPS regional teams, along with the ASR:
- Ensure Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations.
- Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.
Adverse Event & Periodic Safety Reporting
- Partners with GPS regional teams and any other relevant functions to ensure the preparation of periodic safety reports of assigned TA' products (J-DSUR, J-PSUR, Non-Serious Unexpected ADR Periodic Safety Report and Re-examination dossier).
Audits and Inspections
- Along with the ASR, responsible for the development and tracking of CAPA in response to observations related to Safety Science team activities in a timely manner.
Partnership with business partner with possibility for identification and/or handling of safety information
- In collaboration with the GPS Regional PV Teams, acts as key responsible person for affiliate cross-functional partners on safety topics to address business needs and ensure that business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements, and that applicable PV and safety data exchange agreements are implemented.
PV Training
- Collaborate with the GPS regional teams, along with the ASR, collaborate with the GPS Regional teams to ensure overall training compliance with corporate procedures and local PV requirements.
Risk Management
Collaboration with the GPS Regional team is essential for the following tasks. Do refer to the DOP and JPN GL 04, which are defined separately, for more details.
- Represents PV as a member of the Affiliate Risk Management Team (ARMT) for an assigned TA and Product, when applicable and coordinates the receipt and distribution of RMP, Core Implementation Plan (CIP) and additional risk minimization measures (aRMM) to ARMT members.
- Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products.
- Liaises with ARMT & Benefit Risk Management (BRM) Team and where applicable, seek involvement of relevant GPS stakeholders during development or revision of the Japan Specific Annex, LIP and local aRMM.
- Performs the assessment and implementation of the CIP and accompanying aRMM, when applicable.
Safety Monitoring
- Develop a deep knowledge of the assigned TA - disease knowledge, product knowledge, safety profile, benefit risk information, and the competitor landscape.
- Effectively communicate safety information to stakeholders to positively impact educational strategies and business strategies such as launch excellence; patient experience; emerging safety information.
- Through local safety monitoring, detect opportunities that add value to the understanding of the use of the assigned TA and products. Performs surveillance of Local Safety Information and communicates regularly to AMD and the GPS Regional teams.
- Build strong partnerships and work collaboratively with stakeholders and other functions across the business, such as Regulatory Affairs, MA assigned, Brand Teams, as applicable.
Launch Readiness
Collaborating with the GPS regional teams, along with the ASR, sets a solid local safety & PV strategy incorporating proactive PV contributions to ensure a successful product/indication launch at the affiliate.
PV Advocacy
Collaborates on internal and external PV advocacy efforts, in alignment with the AbbVie, GPS, and QPPV Office advocacy guidance.
Affiliate Review Process for research
- Review the assigned TA and products PMSS (both regulatory and non-regulatory) and medical research protocols from a safety perspective.
- Participate in the assigned TA Japan Review Committee to provide appropriate input from a safety perspective.
INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:
- Affiliate MD
- Affiliate TA heads
- Business Unit
- Japan Development
- MHLW / PMDA
- IMA
- PSE
資æ ¼
IDEAL CANDIDATE:
- Bachelor's degree (Pharmaceutical Science) â Required
- Master degree, PhD or MD â Ideally
- Experiences on J-GVP activities - Required at least 5-7 years experiences under the most updated regulations.
- candidates with 3 years of experience in pharmacovigilance (PV) together with relevant medical experience (such as Medical Affairs or PMS), which can be counted in total, will also be considered.
- Japanese skills â Native level or equivalent; highly proficient and able to use Japanese fluently for business purposes.
- English skills â Speaking, Reading and Writing at business level.
- Quality mind-set.
- Solution-focused with broad system thinking.
- Excellent communication skills.
- The ability to give attention to detail and evaluate.
- Flexible and pro-active.
CRITICAL SUCCESS FACTORS:
Job-related high-level specialized skills:
- Deep knowledge and experience in Pharmacovigilance
- Creation and maintenance of J-RMP and additional risk minimization tools in communication with internal and outside stakeholders (PMDA, Head Office, PMS etc.)
- Well understanding of the contents of PSUR/PBER and DSUR from scientific viewpoint
- Deep knowledge of Pharmaceutical Affairs Law, GVP/GPSP ordinances, and related business practices
- Fundamental medical and pharmaceutical knowledge
- Risk management
- Compliance
General skills:
- Information gathering and analysis ability
- Logical thinking ability
- Active listening
- Negotiation skills
Mindsetï¼
- Patient Centricity
- All for one AbbVie
- Decide Smart and Sure
- Agile and Accountable
- Clear and Courageous
- Make Possibilities Real
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