Safety Pharmacovigilance (PV) Mgr

Job Description

Company Overview

Job Description
Safety Pharmacovigilance (PV) Mgr

Group Purpose
Facilitate patient access to the company's products in Japan through the following: compliance with applicable local regulations; development and maintenance of local business processes in pharmacovigilance (PV) and post marketing surveillance (PMS), integrated in relevant the processes; development and execution of Japan risk management plan (J-RMP); assessment of safety data in Japan; provision of safety expertise; leading and collaborating on post marketing surveillance (PMS) activities; interface with regulatory agencies and industry organization; alignment with key cross-functional partners and business partners; continuous improvement of business processes

Job Summary
As part of the Japan Safety organization at the company, the Japan Safety PV Mgr is responsible for: representing the local safety function in interactions with Regulatory agencies, other functions within the company, staff members in Global Patient Safety, business partners, and external health care professionals, to achieve Safety objectives; helping ensure compliant and efficient performance of local safety activities based on sound knowledge of local legislative requirements and practice, the company policies and procedures; and participating in exchange of safety information with stakeholders (partners, and external; local, regional, and global) to support informed understanding of product safety issues.

Key Activities

Execute safety (PV) processes for products
Represent the Safety function on local product team(s) and joint product team(s)
Ensure safety compliance review and quality of safety part of CTN and NDA dossiers in Japan
Contribute to and facilitate the creation and improvement of local business processes and system infrastructure for safety information collection and management
Safety Reporting and Safety Database

Facilitate Safety Database conventions development and maintain current awareness of those conventions
Perform assigned tasks in the ICSR handling workflow and the preparation and submission of Japan-specific periodic safety reports
Facilitate development of productivity and compliance metrics for AE processing
Risk Management and Risk Communication

Collaborate with cross-functional stakeholders on risk management planning and local risk minimization actions
Compliance and Regulatory
Advocate safety compliance
Prepare for and participate in regulatory inspections by Regulatory Authorities
Negotiate with local regulatory agency officials on safety related topics
Training and Other Cross-functional Activities
Lead and educate safety associate for safety activities
Develop Safety data exchange agreements and memorandum of understanding (MOU) using Globally consistent formats
Train the company and the employees on safety reporting needs in Japan
Participate in global/regional/country safety meetings to share best practice

Knowledge and Skills

​Experience in directly related to safety areas including PV regulations
Defining, authoring, and implementing policies, procedures and SOPs
Project management skills
Communication skills and ability to collaborate in cross-functional team settings
English language proficiency (business discussions, reading, and writing)
Work experience in the planning and execution of pharmacovigilance and safety surveillance activities during clinical development and in the post-marketing setting. (Preferred)
Current nursing or paramedical professional license or Pharmacist. (Preferred)