PV Officer, Team Lead (Japanese fluency required)
WFA Digital Insight
The demand for pharmacovigilance specialists has seen significant growth, with a 25% increase in job postings over the past year. As the remote job market continues to evolve, companies like Ergomed are looking for skilled professionals to lead their teams. With the life science industry expanding rapidly, professionals with expertise in ICSR management and strong leadership skills are in high demand. Ergomed stands out for its commitment to diversity, equity, and inclusion, making it an attractive option for those seeking a supportive work environment. Before applying, candidates should be prepared to showcase their experience in pharmacovigilance, team management, and client cooperation, as well as their fluency in English and Japanese.
Job Description
About the Role
The PV Officer, Team Lead position at Ergomed is a critical role that entails leading a team responsible for ICSR management for selected projects or groups of projects. As a Team Leader, you will be responsible for ensuring the adequate distribution of tasks, overseeing the workflow process, and maintaining effective cooperation with clients. Your expertise in pharmacovigilance and team management will be essential in driving the success of the project team.The role is based in South Korea and requires fluency in both English and Japanese. As a leader in the pharmacovigilance team, you will be working closely with the ICSR Operational Lead to manage ICSR deviations, review trackers and timesheet data, and ensure the accuracy of the data. Your ability to communicate effectively with clients, team members, and stakeholders will be crucial in this position.
Ergomed is a specialized mid-size pharmacovigilance service provider that has achieved global organic growth year after year. With staff based across Europe, North America, and Asia, the company provides first-class support to its pharmaceutical and biotechnology partners. As a Team Lead at Ergomed, you will be part of a dynamic team that prioritizes diversity, equity, and inclusion, and offers a human-centric environment where people can contribute and grow.
What You Will Do
- Lead a team of ICSR staff and manage the workflow process to ensure effective cooperation with clients
- Create and maintain project-specific KPIs for contracted ICSR activities
- Propose process changes to the ICSR Operational Lead to increase team efficiency
- Manage ICSR deviations with the support of the ICSR Operational Lead
- Review trackers and timesheet data to ensure accuracy
- Operate as the assigned team SME and support other SMEs
- Provide support to other activities undertaken by the project team on behalf of the client and the company
- Line manage assigned ICSR staff and ensure their training and development
- Collaborate with the ICSR Operational Lead to manage ICSR processing and 2nd QC of cases
- Ensure compliance with regulatory requirements and company policies
What We Are Looking For
- Life science graduate, pharmacy, nursing, or other healthcare-related qualification
- Extensive experience in pharmacovigilance, including demonstrated work experience in a line manager role
- Excellent communication skills (written and verbal) in English and Japanese
- Strong organization skills, including attention to detail and multitasking
- Ability to delegate tasks and manage team members effectively
- Planning and time management skills
- Technical skills, including proficiency in Excel
- Team working and collaboration skills
- Experience in managing ICSR teams and projects
- Knowledge of regulatory requirements and company policies
Nice to Have
- Experience in managing pharmacovigilance projects in a global setting
- Knowledge of medical device regulations and pharmacovigilance requirements
- Certification in pharmacovigilance or a related field
- Experience in using project management tools and software
- Fluency in other languages, such as Korean or Chinese
Benefits and Perks
- Competitive salary and benefits package
- Opportunities for training and career development
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world
- English as the company language
- Access to cutting-edge technology and tools
- Flexible working hours and remote work options
- Health and wellness programs
- Recognition and reward for outstanding performance
- Paid time off and holidays
- Employee assistance program
- Professional development and networking opportunities
How to Stand Out
- To stand out as a candidate, highlight your experience in ICSR management and team leadership, and emphasize your fluency in English and Japanese.
- Make sure to showcase your technical skills, including proficiency in Excel and any other relevant software.
- Prepare examples of your experience in managing pharmacovigilance projects and teams, and be ready to discuss your approaches to quality control and regulatory compliance.
- Research Ergomed's company culture and values, and be prepared to discuss how you can contribute to the team and grow with the company.
- Be prepared to ask questions about the role, the team, and the company, and show your enthusiasm for the position and the industry.
- Consider creating a portfolio or samples of your work to demonstrate your skills and experience in pharmacovigilance and team management.
- Be prepared to negotiate your salary and benefits package, and do your research on the market rate for similar positions in the industry.
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