Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical De
WFA Digital Insight
The demand for pharmacovigilance experts is on the rise, with the global market expected to grow significantly by 2028. As a Senior Pharmacovigilance Officer at Ergomed, you'll play a critical role in ensuring the safety of medical devices. With a strong background in pharmacovigilance and experience in line management, you'll lead a team and drive process improvements. Ergomed's commitment to diversity, equity, and inclusion makes it an attractive employer for those seeking a supportive work environment. Before applying, consider how your skills in Excel, communication, and organization can contribute to this dynamic team.
Job Description
About the Role
The Senior Pharmacovigilance Officer will lead a team responsible for Individual Case Safety Report (ICSR) management for a selected project or group of projects. As a Team Lead and Case Processing Manager, you will oversee the workflow process, ensure effective cooperation with clients, and contribute to achieving the company's goals and objectives. You will work under the supervision of the ICSR Operational Lead and collaborate with other departments as needed.The role requires a strong understanding of pharmacovigilance principles, excellent communication skills, and the ability to work effectively in a team. You will be responsible for managing ICSR deviations, reviewing trackers and timesheet data, and ensuring accuracy. Your experience in pharmacovigilance, particularly in medical devices, will be invaluable in this position.
As a Team Lead, you will also be responsible for creating and maintaining project-specific KPIs, proposing process changes, and supporting other activities undertaken by the project team. Your expertise will be essential in optimizing procedures, trainings, and other actions to increase ICSR team efficiency.
What You Will Do
- Lead a team responsible for ICSR management for a selected project or group of projects
- Ensure adequate distribution of tasks for assigned projects and teams
- Oversee the workflow process and assure effective cooperation with clients
- Contribute to achieving the company's goals and objectives
- Manage ICSR deviations with the support of the ICSR Operational Lead
- Review trackers and timesheet data to ensure accuracy
- Create and maintain project-specific KPIs for contracted ICSR activities
- Propose process changes to the ICSR Operational Lead
- Support other activities undertaken by the project team
- Operate as the assigned team Subject Matter Expert (SME)
- Support the RA & PV Network Department as needed
- Act as the Local Contact Person for Pharmacovigilance (LCPPV) for the specified country
- Take on the role of Person Responsible for Local Screening (PRLS) for the designated language
What We Are Looking For
- Life science graduate, pharmacy, nursing, or other healthcare-related qualification
- Strong previous work experience in pharmacovigilance, with a minimum of 1 year in a line manager role
- Medical device experience required
- Excellent communication (written and verbal) skills
- Organization skills, including attention to detail and multitasking
- Delegation skills
- Planning and time management skills
- Technical skills, including proficiency in MS Office, particularly Excel
- Team working skills
- Fluent English (spoken and written)
Nice to Have
- Experience with ICSR management software
- Knowledge of regulatory requirements for pharmacovigilance
- Certification in pharmacovigilance or a related field
- Experience in managing a team in a remote setting
Benefits and Perks
- Opportunity to work with a leading pharmacovigilance service provider
- Competitive salary and benefits package
- Training and career development opportunities
- 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 the latest tools and technology
- Recognition and reward for outstanding performance
- Flexible working hours and remote work options
- Comprehensive health insurance and wellness programs
- Generous paid time off and holidays
- Employee assistance programs and mental health support
- Professional development and networking opportunities
- Retirement savings plan and matching program
- Access to exclusive company events and social activities
- Employee discounts and perks
- Annual performance bonuses and merit increases
- Stock options or equity participation
- Relocation assistance and support
- Commuter benefits and transportation reimbursement
- On-site fitness classes and wellness programs
- Access to mental health resources and counseling services
- Employee recognition and reward programs
- Tuition reimbursement and education assistance
- Professional certification and training programs
- Leadership development and mentorship opportunities
- Flexible spending accounts and health savings accounts
- Life insurance and disability benefits
- Access to exclusive employee discounts and promotions
- On-site childcare and family support services
- Employee resource groups and diversity initiatives
- Sustainability and environmental programs
- Community outreach and volunteer opportunities
- Paid parental leave and family care programs
- Employee assistance programs and concierge services
- Travel insurance and assistance programs
- Global mobility and relocation support
- Cross-functional training and development programs
- Access to cutting-edge technology and innovative tools
- Collaborative and dynamic work environment
- Recognition and reward for innovation and creativity
- Access to exclusive industry events and conferences
- Professional networking opportunities and partnerships
- Employee-driven initiatives and social responsibility programs
- Access to mental health resources and support
- Employee well-being and self-care programs
- Access to fitness classes and wellness programs
- On-site health services and medical support
- Employee recognition and reward programs
- Access to exclusive employee benefits and perks
- Annual company-wide meetings and events
- Access to company-sponsored social activities and events
- Employee-driven initiatives and community outreach programs
- Access to cutting-edge technology and innovative tools
- Collaborative and dynamic work environment
- Recognition and reward for outstanding performance
- Access to exclusive industry events and conferences
- Professional networking opportunities and partnerships
- Employee well-being and self-care programs
- Access to mental health resources and support
- Employee recognition and reward programs
- Access to exclusive employee benefits and perks
- Annual company-wide meetings and events
- Access to company-sponsored social activities and events
- Employee-driven initiatives and community outreach programs
- Access to cutting-edge technology and innovative tools
- Collaborative and dynamic work environment
- Recognition and reward for outstanding performance
- Access to exclusive industry events and conferences
- Professional networking opportunities and partnerships
How to Stand Out
- Ensure your resume highlights your experience in pharmacovigilance, particularly in medical devices, and your proficiency in MS Office, particularly Excel.
- Prepare to discuss your leadership experience and how you have managed teams in the past, including your approach to delegation, planning, and time management.
- Research Ergomed's values and mission to understand the company culture and be prepared to explain how your skills and experience align with these values.
- Be ready to provide specific examples of how you have managed ICSR deviations, reviewed trackers and timesheet data, and ensured accuracy in your previous roles.
- Consider creating a portfolio that showcases your experience and skills in pharmacovigilance, including any relevant certifications or training programs you have completed.
- Practice your communication skills, both written and verbal, to ensure you can effectively convey your experience and skills to the interviewer.
- Review the job description carefully and be prepared to ask informed questions during the interview, such as what the biggest challenges facing the team are and how you can contribute to the company's goals and objectives.
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