PV Digital Excellence Team Lead

The Pharmacovigilance Digital Excellence Team Lead is responsible for overseeing the development, implementation, and maintenance of technology solutions that support pharmacovigilance activities. This role involves leading a team of professionals to ensure the efficient and effective use of technology in monitoring, assessing, and reporting adverse drug reactions and other safety issues. This role also includes leading improvement projects focused on data and technology in pharmacovigilance operations.

Responsibilities

• Leadership and Management: Provide strategic direction and leadership to the PV Digital Excellence Team, ensuring alignment with organizational goals and regulatory requirements.
• Improvement Projects: Lead improvement projects focusing on pharmacovigilance operations from a data and technology perspective.
• Technology Implementation: Oversee the development and implementation of pharmacovigilance systems and tools, ensuring they meet industry standards and regulatory guidelines.
• Data Management: Ensure the accurate collection, analysis, and reporting of pharmacovigilance data, utilizing advanced data management and analytics tools.
• Compliance and Quality Assurance: Ensure all pharmacovigilance activities comply with regulatory requirements and internal quality standards.
• Collaboration: Work closely with cross-functional teams, including clinical, regulatory, and IT departments, to integrate pharmacovigilance technologies into broader organizational processes.
• Training and Development: Provide training and development opportunities for team members to enhance their skills and knowledge in pharmacovigilance technologies.
• Innovation: Stay abreast of emerging technologies and trends in pharmacovigilance, and drive continuous improvement initiatives within the team

Your profile

• Educational Background: Advanced degree in a relevant field such as Pharmacy, Medicine, Life Sciences, or Information Technology.
• Experience: Minimum of 5 years of experience in pharmacovigilance, with at least 2 years in a leadership role. Experience with pharmacovigilance systems and technologies is essential.
• Technical Skills: Proficiency in pharmacovigilance software (ArisGlobal, Veeva Safety,Argus), data analytics tools, and database management systems.
• Regulatory-PV Knowledge: In-depth understanding of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
• Leadership Skills: Strong leadership and team management skills, with the ability to motivate and develop a high-performing team.
• Analytical Skills: Excellent analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions.
• Communication Skills: Strong verbal and written communication skills, with the ability to effectively communicate technical information to non-technical stakeholders.
• Project Management: Proven project management skills, with the ability to manage multiple projects simultaneously and deliver results on time and within budget.
• Innovation and Adaptability: Ability to drive innovation and adapt to changing technologies and regulatory environments.

We provide

• Great opportunity for professional development in an innovation driven department
• Great reputation at a well established pharmaceutical firm
• Stability and a trustworthy workplace
• Work in multidisciplinary teams
• Training and development opportunities
• Medical services and life insurance
• Various sport and health opportunities
• Excellent work life balance