We're looking for people who are determined to make life better for people around the world.
Interested? Then become part of our team and start as soon as possible as:
Deputy European Union (EU) Qualified Person for Pharmacovigilance (m / f / d) What challenges await you?
Deputise for the European Union QPPV as required and according to delegation and specifically to fulfil the legal and regulatory requirements for the QPPV role in his or her absence.
Provide strategic and technical pharmacovigilance advice to Global Patient Safety (GPS), and other regulatory and medical functions within the Medicines Development Unit.
Play an active role in the GPS Leadership Team, Safety Review Committee (SRC) and other committees as required.
Provide training, coaching, and mentoring, demonstrating Global Patient Safety expertise and leadership.
Deputise for the EU QPPV on the Global Product Labelling Committee (GPLC) as required.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Fulfil the legal and regulatory requirements for the EU Qualified Person responsible for pharmacovigilance role as defined by prevailing European legislation and guidelines in the absence of the EU QPPV or as delegated by the EU QPPV.
Ensure appropriate cover with the QPPV including provision of all the necessary information to fulfil the role.
Maintain current awareness of the evolving EU regulatory environment, provide timely feedback to GPS leadership, and provide advice to the Medicines Quality Organisation as appropriate.
Review and provide expert input to EU regulatory submissions PASS protocols and actions taken in response to emerging safety concerns in order to ensure appropriate risk minimisation and the timeliness, correctness and completeness of all pharmacovigilance data submitted to the Competent Authorities and to the European Medicines Agency (EMA).
Provide QPPV input to GPLC in the absence of the QPPV or as delegated.
Fulfill all other QPPV obligations as stipulated in the Good Vigilance Practice (GVP) guidelines as delegated by the QPPV.
Provide an independent expert viewpoint on specific safety issues.
Maintain links with Global Regulatory Affairs and provide technical consultancy to safety sections of European regulatory submissions, responses to Committee for Medicinal Products for Human Use (CHMP) / other European regulatory authority safety questions, and guidance on safety sections of Summary of Product Characteristics, etc.
Provide technical leadership through active external involvement in pharmacovigilance forums and bring shared learning back into the Lilly organization.
Provide training, coaching and mentorship to safety surveillance scientists, and other Global Patient Safety Medical physicians and clinical research scientists and to other medical and regulatory functions in the MDU and business units as appropriate.
Participate in recruitment and succession planning activities and provide advice regarding potential candidates as requested (managerial and physician positions), if required.
How do you convince us?
Medical degree, and clinical experience.
Global focus; residency and operation in the EU / EEA.
A minimum of 5 years' experience in pharmacovigilance; understanding of epidemiology principles is important.
Problem solving skills, sound clinical judgement; decision making capability in pressurized circumstances.
Strong influencing, coaching, and negotiating skills across multiple internal and external audiences and levels of seniority.
Strong interpersonal, team working, writing, presentation, and communication skills.
Data-driven; ability to work effectively in a multi-cultural environment, team structure and independently.
Current awareness of product safety regulatory environment; ability to communicate and translate into company processes.
Broad knowledge of drug development and clinical research business development processes and needs.
Good understanding of quality systems, epidemiology principles and benefit risk methodologies.
Strong internal and external networks and focus on shared learning.
Flexibility and willingness to operate out of usual office hours.
Ability to travel.
What can you look forward with us?
Working atmosphere: We treat each other as equals at all levels and value our team spirit Eye-To-Eye Working culture.
Creative flexibility: From the very beginning, you will have the freedom to contribute and implement your ideas. You can shape your area of responsibility independently or as a member of cross-functional or self-organised teams.
Further Development: We value supporting our employees individually in their career development and at the same time guarantee fair access to professional development worldwide via our "Corporate Lilly University".
Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits.
Are you interested? Then please do not hesitate to apply online via our website. We are looking forward to your application!
For any further questions please contact:
Aslihan Bulut
Phone: +49 (221) 65083640
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
WeAreLilly
#J-18808-Ljbffr
