About the role

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job Summary:

The Senior Pharmacovigilance (PV) Manager, QPPV Office leads a team of PV Consultants and PV Coordinators to support local and global PV services for ProPharma clients such us e.g., EU or UK Qualified Person responsible for Pharmacovigilance (QPPV), Local Person responsible for Pharmacovigilance (LPPV), maintenance of Pharmacovigilance System Master Files (PSMF) and regulatory intelligence (RI).

The Senior Manager takes over the role of the QPPV or LPPV for ProPharma clients and serves as Subject Matter Expert (SME) for assigned PV areas.

Essential Functions:

Leadership responsibilities:

• Provides guidance and leads the team.
• Supports hiring and induction of team members.
• Prepares the annual performance management plan with the team members, conducts mid-year & end-year review appraisals
• Ensures that all team members understand team objectives and work together to achieve them.
• Identifies individual and team development needs and plan to meet these in conjunction with the learning and development team.
• Develops succession plans for key roles in the team.
• Promotes and supports effective team working through good communication and regular individual and team meetings.
• Resolves team issues and roadblocks in a professional manner to ensure minimal impact on the workflow.
• Provides support, knowledge, and training to team members to build and improve skills and improve overall performance (e.g., coach and guide staff in all aspects of providing services related to QPPV and LPPV role and PSMF, as applicable).
• Continues to self-develop and stay up to date on market regulations/laws, and trends.
• Manages and oversees QPPV/LPPV projects effectively to ensure that these are within budget, delivered on time and in good quality
• Monitors expenses and team utilization performance to ensure that they are in alignment with the budget.
• Regularly evaluates the team results and workload and suggest adjustments in the business plan to the Vice President, QPPV Office, if necessary.
• Ensures ongoing and planned projects are adequately staffed and manage resource utilization within the team effectively.
• Ensures that the day-to-day activities within the team are running smoothly and deviations/bottlenecks are addressed and taken care of.

Operational responsibilities:

• Collaborates with ProPharma Business Development and Client Services to set-up budget proposals for QPPV office activities, where needed.
• Attends Bid Defense Meetings with potential clients, as required.
• Accountable for the implementation of global and local PV services for clients and overseeing successful service delivery from operational perspective.
• Assuming positions for clients like the QPPV or the LPPV which may include the Graduated Plan Officer in Germany or the National Contact Person (NCP) in UK.
• Input and updates of the current QMS documentation relevant for the QPPV office process including client specific Working Practices and associated Work Instructions.
• Develops and delivers PV training.
• Supports client audits and inspections.
• Serves as an QPPV or LPPV according to the applicable Role Description.

Necessary Skills and Abilities:

• Excellent written and oral communication skills. 
• Ability to communicate effectively within the PV organization and cross-functionally and with all levels.  
• Excellent planning, prioritization, and organizational skills.
• Self-motivated and ability to motivate others.  
• Excellent decision making and problem-solving skills.  
• Able to liaise and negotiate efficiently with clients to ensure the client needs are met. 
• Able to work within a team in an open and professional manner 
• Ability to delegate effectively.  
• Strong focus on continuous improvement of processes, procedures, business activities etc.  
• Ability to proactively identify efficiencies and provide the business case for change.  
• Excellent attention to detail and focus on quality.  
• Ability to manage multiple projects. 

Educational Requirements:

University Degree (BSc EQF level 6, MSc EQF level 7, or PhD EQF level 8), in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, nursing, life science, medical technology or biology.

Experience Requirements:

• Minimum of 5 years’ experience in clinical and/or post-marketing pharmacovigilance. 
• Minimum of 2 years’ QPPV office experience.  
• Experience in leading and developing a (project) team. 
• Expert knowledge of global pharmacovigilance practices and regulatory requirements incl. MHRA and EU PV legislations and guidances.