Purpose of role
Lead the Drug Safety department with responsibility across all territories except for the US and Canada, in compliance with current national and international regulatory and GxP requirements.
Key Responsibilities –
- Responsible for the development of the Drug Safety team responsible for post-marketing pharmacovigilance and clinical safety such that it is best positioned to protect patient safety and to optimally support all stakeholders.
- Ensure compliance of all drug safety related tasks with all applicable legislation
- Work in close collaboration with the EU-QPPV for all post marketing safety aspects of the Mundipharma products authorized and marketed in the EEA.
- Ensure provision of data and information for QPPV oversight
- Oversee epidemiological investigations and Non-interventional studies; Line Management of a Senior Epidemiologist.
- Provide strategic safety input for R&D projects and due diligences.
- Manage the clinical safety aspects of drug development programs to ensure early identification of safety issues and initiation of proper risk mitigation measures.
- Work on continuous process development and improvement to cover the key areas of drug safety such as risk management, signal detection and regulatory intelligence for safety reporting.
- Representing the Mundipharma Research Drug Safety team within the worldwide pharmacovigilance system of the Purdue/Mundipharma/Napp independent associated companies and actively participate in the regular meetings of the Signal Evaluation group.
- Organise and implement adequate vendor oversight instruments fit for purpose for the current outsourcing model at Mundipharma Research and establish appropriate KPIs and metrics to control vendor performance for reporting to the EU-QPPV.
- Lead, train, motivate and develop the people within Drug Safety to ensure high quality results and a collaborative way of working.
- Provide medical expertise to the team.
- Establish Drug Safety training programs in collaboration with the EU-QPPV.
- Develop and maintain interfaces with other departments to ensure appropriate communication and input to relevant benefit risk assessments.
- Building and maintaining strong partnerships with the Mundipharma IACs and 3rd party companies to ensure a consistent functioning of the PV system and a swift addressing of any challenges that may arise
- Responsible for delivering on company goals, priorities and culture through participation in the Mundipharma Research Senior Leadership Team
- Undertake any other reasonable tasks requested by the Managing Director of Mundipharma Research within the competency of the position owner
Key Skills required for the role
- Qualified physician (MD) with significant experience in the pharmaceutical industry or a CRO and substantial knowledge of the post marketing and clinical safety
- Significant experience of working with regulatory authorities in both clinical and post-market areas
- Familiar with working in an outsourcing model; experienced with setting up and managing vendor oversight.
- Detailed knowledge of applicable guidelines, laws, and best practices in drug safety.
- Experience and detailed knowledge of clinical development, regulatory affairs, and quality assurance.
- Understanding of working in a multicultural, global environment with companies that follow varying national regulations outside the EEA
- Significant experience in strategic planning, coupled with successful implementation of processes.
- Excellent leadership and project management skills
- Ability to work effectively with teams to achieve results; evidence of developing the talent of others, ability to mentor.
Personal and Leadership Characteristics
- Excellent leadership skills with both practical and short/long term strategic vision; ability to build relationships and inspire confidence and respect at all levels; strong team player.
- Excellent communicator – able to build rapport and demonstrate strong influencing and negotiation skills; excellent listening skills – receptive to feedback and demonstrates flexibility, curiosity and an ability to learn.
- Demonstrates and encourages ownership and responsibility; drive/motivation – has a “can-do” attitude and is committed to delivering results and strives for continuous improvement.
- A good blend of strategic and analytical thinking; innovative personality; able to see the bigger picture and set direction for the future.
- Consistently demonstrates and encourages others to demonstrate the Company’s Core Values; Honesty, Respect, Passion, Innovation and Commitment.
- Strong ethical standards and a high level of personal integrity.
- Adheres to the Company’s Compliance and Code of Business Ethics guidelines.