Deputy European Union (EU) Qualified Person for Pharmacovigilance

Deputy European Union (EU) Qualified Person for Pharmacovigilance

Eli Lilly Benelux

Multiple Locations, Europe

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 /mentoring and demonstrating Global Patient Safety expertise and leadership;
• Deputise for the EU QPPV on the Global Product Labelling Committee (GPLC) as required.

Primary Responsibilities:

Deputise for the EU Qualified Person for Pharmacovigilance

• 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 fulfill 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;
• Play an active role in the GPS Leadership Team, SRC and other committees including GPLC as appropriate ; provide strategic and technical advice to these committees as well as to the global regulatory and medical organizations;
• 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?

If you can look back on the following successes in your career to date, you bring the best prerequisites with you:

• 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.

Apply Now

More Job Searches

Multiple Countries      Clinical Research      Pharmacovigilance and Medical Information      Pre-clinical Research and Development      Eli Lilly Benelux