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About the Role
SERM Physician will provide responsibility for the continued safety assessment, evaluation and risk management of GSK Japan products in clinical development and/or the post-marketing setting. This contributes to keep patients using GSK Japan marketed products be safe. To ensure adverse event and other safety information is efficiently evaluated in order to meet regulatory requirements and drive proactive implementation of safety management initiatives. To support Japanese drug development from safety perspective and provides safety input from medical perspectives to relevant colleagues in GSK Japan and GSK Global.
Responsibilities
- Perform risk identification, assessment and mitigation activities throughout product lifecycle for patient safety
- Medical review of individual case safety information and periodic safety data for products
- To medical review and ensure quality of the documents to be submitted to regulatory authority and/or distributed external stakeholders
- To contribute safety aspect for J-NDA and negotiating with regulatory authority
- Participation in safety-related meetings
- To input proactively safety information on developing drugs with Japan project team from medical perspectives
- Medical review and provide medical advice on safety-related aspects to relevant colleagues in GSK Japan and GSK Global not limited to clinical safety and pharmacovigilance division in Japan
Requirements
- Physician's competency, including medical knowledge, understanding patient perspectives, experience in managing patient care, having sound judgement in benefit/risk evaluation on patient safety issues, and working in the Japanese healthcare environment
- Ability to make independent clinical assessments and decisions, based on professional and scientific responsibilities
- Integrity and strong feeling for ethics
- Strong team spirit
- Capable of self-development and curiosity about new technology
- Resilience
- Having 5 or more years of clinical experience as a physician.
- Medical degree in Japan
- Writes and Speaks fluent Japanese at native level / Business level English in reading/ writing/ speaking
- Must have the legal right to work in Japan.
- Self motivated, flexible and goal oriented
- Grasps scientific data quickly, understands its interpretation and implications and drives to results based on its use
- Ability to be an inclusive team player, communicating at all levels
- Leadership
- Preferred expertise in epidemiology and public health, ability to analyze large datasets
- Minimum 3-5 years of industry experience, especially in a PV function, with leadership experience.
- Experience presenting at academic conferences and publishing scientific papers as lead author
- Participated in a pre-approval clinical trial or a clinical study
- Having a specialist qualification in your area of expertise or a doctorate
Skills
- Physician's competency
- Medical knowledge
- Understanding patient perspectives
- Experience in managing patient care
- Benefit/risk evaluation on patient safety issues
- Working in the Japanese healthcare environment
- Independent clinical assessments and decisions
- Professional and scientific responsibilities
- Integrity
- Ethics
- Team spirit
- Self-development
- Curiosity about new technology
- Resilience
- Self motivated
- Flexible
- Goal oriented
- Grasping scientific data
- Data interpretation
- Data implication understanding
- Inclusive team player
- Communication at all levels
- Leadership
- Epidemiology expertise
- Public health expertise
- Large datasets analysis
- Industry experience
- PV function experience
- Presenting at academic conferences
- Publishing scientific papers
- Clinical trial participation
- Digital Fluency
- Enterprise Leadership
- Influencing Without Authority
- Pharmacovigilance
- Presentation Techniques
Location
- Japan
Work Type
- Agile working culture
Experience Level
- 5 or more years of clinical experience as a physician
- Minimum 3-5 years of industry experience, especially in a PV function, with leadership experience.
Education Level
- Medical degree in Japan
- Specialist qualification in your area of expertise or a doctorate
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.
- People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.
- Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.