Pharmacovigilance Quality & Compliance Manager
About this opportunity
Job title: Pharmacovigilance Quality & Compliance Manager
Location: Tokyo
----------------
Job role
Fulfill responsibility that processes to comply with local PV regulations and the global procedures are implemented, documented and followed locally (QD management, self-inspection, etc.)
Fulfill responsibility on creation and revision of SDEA, PV contract for safety information exchange and/or GVP and non-GVP agreement. Serves as a consultant/advisor GPV contracts serving Japan PV business.
Fulfil responsibility on storage including document transfer at a transfer of approval. Window person of document management in Japan PV.
Take control Audit and Inspection and its preparation. Coordination of GVP inspection and GxP Audit. Hard knowledge and experience about Audit/Inspection.
Fulfill responsibility to lead Quality in J-PSPV by conducting “self-inspection”, “Change Management, and “Deviation Management /CAPA implementation” . Understand the Global Quality process and implement it to Japan considering local regulation.
Within Japan organization, to be a window person of training about general topic and local regulation for safety mutters. Keep communication to global training leader and implement to Japan. Leader of Japan GVP training program.
Personal requirements
Ability to create and implement appropriate safety processes from quality and compliance standpoint.
High level of coordination, communication and negotiation skills.
Solid knowledge of audit/inspection, experience with Japan GVP.
Commitment and ethical standard to fulfill responsibility in keeping SaKK in compliance with both global and local PV regulatory obligations
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !
Job details
How this role compares
Computed from every other active role in our database, not just this employer's listings.
We don't have enough classified peer data for this role yet, so there's no comparison to show. This happens when a posting's title/category doesn't match any taxonomy rule -- it's excluded rather than compared against the wrong peer group.
More open roles
We can't rank similar roles for this posting, so these are current openings at Sanofi KK (Japan) and related roles in Japan.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.