Basic purpose of the job

1.Lead safety risk management activities related to labeling and risk communication strategy which fulfils compliance with BI’s internal procedures and local regulation.

2.Prepare and maintain local package insert and risk communication strategy as risk minimization plan based on safety specification.

3.Ensure CCDS compliance and operation for risk communication including dissemination of J-PI change notification, EPPV activities and other risk communication such as DHCPLs in compliance with GVP and GPSP regulations.

Accountabilities

Coordinate revision of J-PI (Japanese Package Insert) according to CCDSs (Company Core Data Sheets)

which Boehringer Ingelheim Corporate develops to harmonize JPI with global safety information

Related performance indicators

Ensure CCDS compliance in a timely manner

Take necessary measures, such as the revision of J-PIs, to ensure patient safety based on the requests/ instructions from the authorities (MHLW, PMDA), and provide safety information to the medical institutions adequately

Related performance indicators

Ensure J-PI timeline and quality

Plan and conduct “Early Post-marketing Phase Vigilance” ( EPPV) and Carry out operations related to safety risk communication

Related performance indicators

Ensure EPPV activities operation and quality operations for risk communication

Develop expertise, know-how and competency of subordinates

Related performance indicators

Ensure all concerned staffs have knowledge and skills for labelling and risk communication

Create and maintain local PV agreements

Related performance indicators

Ensure PV agreements prepared in a timely manner

Ensure archiving of PV/GVP/GPSP related documents and its vendor management according to local GxP

Related performance indicators

Ensure internal procedure and external regulation

Support local inspection readiness, participate in PV audits and PV/GPSP inspections and conduct self-check

for GVP/GPSP activities as required and contribute to CAPA processes as appropriate

Related performance indicators

Ensure local inspection readiness

Prepare SOPs and WIs and Collaborate with other teams within PSPV or Clinical teams and Marketing teams on safety issues

Related performance indicators

Prepare SOPs, WIs and WMs satisfying Corporate SOPs and local regulations

Regulatory and / or Organisational Requirements

・Knowledge of local and international PV regulation

Interfaces

Local Medical Director, Global Patient Safety & Pharmacovigilance, MSG, GQP Manager, Primary care medicine, LRA, QMMR, MKT, SL GRA, GL

Job Expertise

・3+years’ experience in pharmacovigilance

Job Impact

Conduct and Establish internal/external collaborations by sharing best practices

Minimum Education/Degree Requirements

Bachelors Degree　

Required Capabilities (Skills, Experience, Competencies)

• At least 3 years of experience in PV work

• Experience in revising electronic attachments (electronic accompanying documents),

including dealing with authorities (experience in providing information to medical institutions is also helpful)

• Knowledge of biology and chemistry to read and interpret CCDS and literature

(mainly in English) and consider whether or not to reflect them in the package inserts

• English level (reading, writing must, speaking must be business level, TOEIC 800

or above expected) to communicate professionally (reading, writing, speaking must,

TOEIC 800 or above expected) with global counterparts.

• Experience in conducting post-marketing surveillance and reporting to authorities

• General understanding of PV regulations (local and global), including RMP

• Ability to communicate and work collaboratively with teams, including other departments

Recruiter : Suzuki

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.