Senior Mgr, Risk Management and Surveillance 2_ Japan
Ref. Number:34350
Location:Japan - Tokyo
Functional Area:Drug Safety & Public Health
Position Type:Regular
Working Hours:Full Time
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Specific Responsibilities
+ Responsible for the following activities in
collaboration with GSI DSPH as appropriate, with minimal supervision
+ Review of local Individual Case Safety Reports
(ICSRs) and identify any trends that need escalation and discussion with DSPH
MSC-RM.
+ Provides monthly metrics on AEs and PMDA reports
to Safety Manager.
+ Participates
in the activities associated with Japanese
Package Insert (J-PI) creation and revision and associated supporting
documentation.
+ Develops
and delivers J-PI revision training to J-DSPH TS and monitors TS compliance
with requirements of J-PI distribution
+ Identifies
requirements and liaises with DSPH MSC-RM on local aggregate safety reports (e.g., J-PSRs) requirements,
supports local report compilation and review and supports submission to PMDA in a timely manner.
+ Identifies
requirements and liaises with DSPH MSC-RM on local J-RMP requirements.
+ Authors
initial and subsequent updates to local risk management plans and supports
development and delivery of associated
training materials as required in
collaboration with the Safety Manager
+ Participates
in the reviews of responses to regulatory agency safety enquiries with DSPH
MSC-RM and applicable functional groups
+ Reviews
local literature on receipt of output from CRO for identification of individual
case safety reports and potential safety concerns and appropriately documents
and manages per applicable SOPs
+ Reviews local translation of essential study
related documents as requested e.g. clinical trial protocols, investigator’s
brochures, study reports, informed consent forms.
+ Reviews marketing materials in a timely manner.
+ Updates the local timeline on aggregate data reports
in collaboration with local Regulatory Affairs and ensures on time submission
of J-PSR, Non-serious unlisted case list, and RMP.
+ Works in close collaboration with GSI DSPH in all
Pharmacovigilance Matters but specifically for the above areas.
+ Collaborates
with Safety Manager, PMS Manager and GMCO as appropriate.
社内外を問わず、会社方針、規則、法律、取締規制など全てにおいて法令順守を徹底して行います。
Ensure
compliance with legal and regulatory requirements, internal
policies/procedures and external codes.
Essential Duties and Job Functions
+ Work is performed withminimumsupervisory direction.
+ Mentors
junior staff to ensure competence in pharmacovigilance skills and knowledge, andinterprets and executes policies
and procedures.
+ Participates in internal educational initiatives
+ Able to gather information or assign tasks or
activities for one or more projectsto
manage competing priority jobs, and delegates special projects to junior staff
if applicable and as needed
+ Demonstrates excellent scientific/clinical or
analytical knowledge base, with ability to assess data and understand the
safety/medical or process implications.
+ Hands-on involvement is a must (effective use of
external resources).
+ Understanding of medical terminology and the
ability to summarize medical information required
+ The ability to assess data and understand the
medical/safety implications
+ Demonstrates excellent verbal and written
communication skills; has ability to provide direction to a team, and to
influence peers and team members appropriately.
+ Develops solutions to a wide range of complex
problems which require the regular use of ingenuity, creativity, and
innovation, ensuring solutions are consistent with organisation objectives; develops concepts,
techniques, standards, and new applications based on professional principles
and theories; viewed as an expert within the organisation particularly in the areas oflocal risk management, J-PSR and J-PI.
+ Drafts and manages the review process for
procedural documents for processes actively involved in.
+ Participates in training, audit and inspection
support.
+ Reviews new regulatory requirements in area of
responsibility, makes recommendations based on impact to existing processes and
oversees implementation
+ Works with applicable teams within DSPH or in
other functions to implement and maintain activities or tasks under the remit
of DSPH
+ Highlights areas of concern to manager; able to
make recommendations for and implement processes for improvement
+ Establishes work priorities with minimal
direction from manager
+ Provides
regular updates to manager, including challenges and suggested actions that
could be taken
+ Able
to maintain confidentiality (especially on patient records), with good
attention to detail and a high level of concern for accuracy and quality
+ Competent
in abilities in area of expertise and some wider areas of DSPH and J--DSPH
+ Maintains compliance with DSPH and applicable
SOPs and work instructions and has an awareness of associated SOPs of other
groups or departments
+ Maintains knowledge of company disease and
therapeutic areas
+ Has an excellent
knowledge and good understanding of applicable regulatory requirements
+ Able to work as a member of a cross-functional
team
+ Actively participates inGSJ and DSPHmeetings and shares information on projects and
challenges openly
+ Acts as a trainer and mentor for more junior J-DSPHpersonnel
+ Able to support or act as back up to presentnew hire safety training
+ Contributes to SOP creation and updates for DSPH
and J-DSPH,andreview
+ Excellent communication skills with individuals
at all levels in the organization
+ Develops solutions to complex problems which
require the regular use of ingenuity and innovation, ensuring solutions are
consistent with organization objectives.
Knowledge, Experience and Skills
+ Experiences in drug safety at least7years.
+ Typically requires a degree (e.g., BS, BA, MSc
or PhD) or professional qualification in a life science field (e.g., nursing or
pharmacy) or a relevant scientific/technical discipline with demonstrated
experience with the responsibilities, deliverables, and skills required for
this level.
+ Registered Pharmacist is preferred
+ Strong familiarity with ICH/local guidelines and
PMDA/MHLW notifications.
+ Good skills of communication in Japanese and
English (>700 TOEIC)
+ Must have demonstrated organizational /project
management skills to manage multiple /complex projects simultaneously.
+ Experiences inlocal RMP, PSR, and PI.
+ Proven good communication skills and evidence of
able to work in cross functional teams
+ Hands-on involvement is a must (effective use of
external resources).
+ Excellent computer skills in Microsoft
environment (Microsoft Excel, Power point and Word).
+ Safety database experience preferred