Team Lead

vor 6 Monaten

Berlin, Deutschland ProPharma Group Vollzeit

For the past 20 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. As the world’s largest RCO (Research Consulting Organization), 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.

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 mínimal 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, PSMF and RI activities, 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.
- University Degree (BSc, EQF level 6), and/or Higher professional training (MSc or PhD, EQF level 7 and 8) in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, nursing, life science, medical technology or biology.
- General medical knowledge
- Note: if not completed basic medical training (in accordance with Article 24 of directive 2005/36/EC) then must have access to a medically qualified person (MAH or ProPharma Group).
- Ideally expertise (or alternatively access to expertise) in relevant areas such as medicine, pharmaceutical sciences, epidemiology and biostatistics. Documented experience in all aspects of PV for a period of five years and experience should be commensurate with the size/complexity of position. Theoretical and practical knowledge in PV systems including experience with different MAHs/ PV systems.
- Good knowledge of EU PV legislation and guidance. Sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the marketing authorization holder.
- Understanding and awareness of related legislation, as well as knowledge about and exposure to PV systems.
- Leadership and Authoritative presence. Ability to influence at senior levels of an organization.
- Managing, organizing and changing processes/systems.
- We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees fe

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