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About the Role
Pharmacovigilance (PV) operations are crucial for protecting the safety of patients using GSK products, operating under strict global regulations. The Safety department collects, evaluates, and acts on safety information for GSK products in compliance with these regulations. This role involves establishing and maintaining systems for collecting and evaluating safety information, including individual case safety reports (ICSRs). A key aspect is optimizing processes and improving efficiency through automation technologies, in collaboration with GSK Global.
Responsibilities
- Establish, maintain, and oversee systems for the appropriate collection and evaluation of safety information, including individual case safety reports (ICSRs).
- Develop and implement end-to-end procedures for safety information collection, database entry, and evaluation in compliance with Japanese regulations and GSK Global requirements.
- Provide direction and manage outsourcing service providers.
- Deliver safety-related training to various stakeholders, including internal teams, GSK Global, license partners, and vendors.
- Report safety information to regulatory authorities and license partners.
- Oversee compliance with the aforementioned processes.
- Develop and improve individual case processing by understanding case operations comprehensively, collaborating with GSK Global, and incorporating automation technologies.
- Manage inspections by regulatory authorities and audits by Global or partner companies, primarily related to individual case processing.
Requirements
- Sufficient understanding of PV-related regulations (GVP, GCP, GPSP) and the ability to propose and implement practical operations and procedural changes.
- Sufficient knowledge of PV activities and management of individual case reports.
- Skills to collaborate with domestic and international stakeholders, and strong communication skills.
- Sufficient English communication skills to participate effectively in meetings with Global teams.
- Business improvement capabilities, including a continuous improvement mindset, problem identification, logical thinking, and problem-solving skills.
- Self-management skills, including effective management of multiple tasks and schedules.
- A proactive attitude towards acquiring new knowledge.
- Proactive ownership and the ability to drive work independently.
- Team leadership capabilities.
- Problem-solving and negotiation skills.
- A minimum of five years of work experience in pharmaceutical pharmacovigilance (PV).
- At least three years of experience in individual case processing activities.
- Experience in post-marketing individual case processing, including cases derived from post-marketing clinical trials and clinical research, as well as clinical trial individual case processing.
Skills
- PV-related regulations (GVP, GCP, GPSP)
- Individual case evaluation and management
- Collaboration with domestic and international stakeholders
- English communication
- Business improvement
- Self-management
- Proactive learning
- Proactive ownership
- Team leadership
- Problem-solving
- Negotiation
- People management capability
- Negotiation skills with Global stakeholders
- Argus case processing experience
- Clinical trial individual case processing experience (3+ years)
- Experience with regulatory authority inspections and audits
- Safety risk management experience
- Experience introducing automation technologies (AI, RPA) into PV operations
- Experience collaborating on Global projects and project leadership
- Digital Fluency
- Enterprise Leadership
- Influencing Without Authority
- Pharmacovigilance
- Presentation Techniques
Location
- Japan
Work Type
- Agile working culture
Experience Level
- 5+ years in pharmaceutical pharmacovigilance
- 3+ years in individual case processing
- 3+ years in clinical trial individual case processing
Education Level
- Pharmacist license or a degree in pharmacy
- Native level in Japanese
- Proficiency in English (fluent communication and report writing)
About the Company
- GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
- We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
- We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
- We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
- Our culture is built on being ambitious for patients, accountable for impact, and doing the right thing.
Equal Opportunity
- We are committed to creating an inclusive workplace and providing equal opportunities for all applicants.
- If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com.