Manager, Risk Management Implementation

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Manager, Risk Management Implementation

AbbVie

Wiesbaden, Germany

As Manager, Risk Management Implementation

Maintain knowledge of current global risk management /minimization legislative requirements and best practice. Guides the Product Safety Team including Benefit Risk Management (BRM) colleagues on potential Affiliate impact due to legislative changes.
In partnership with the RMIL group lead, PST Lead and BRM Lead, provides input to shape the additional risk minimization (aRMz) strategy in the Risk Management Plan (RMP) by applying an understanding of global aRMz requirements.
Utilizes experience and knowledge to provide strategic insight into the Core Implementation Plan (CIP) for products with additional risk minimization (aRMz).
In partnership with the RMIL group lead, guides Additional Risk Minimization working groups and provides advisory input and regional input (including affiliate insights).
Assists in review process for additional risk minimization local implementation plans (LIPs); provides review of LIPs and local or core-modified additional risk minimization measures/tools (escalates to BRM Leads when needed).
Leverages knowledge to help shape the local risk management plan and ensure appropriate reviewers are included based on local country variations.
Supports audits and inspections as it relates to additional risk minimization implementation. Assists affiliates in preparation for discussions with local Health Authorities relating to risk management/minimization as required.

Qualifications

Knowledge of global pharmacovigilance risk management/minimization requirements.
Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
Flexibility to adapt to changing assignments and ability to effectively prioritize.
Project management, interpersonal, and communication skills and ability to work independently and as part of a team.
Willingness and ability to perform international travel up to 15%.
Strong PV risk management/minimization experience is essential, at a global or local level.
Demonstrated experience of supporting product risk management/minimization strategy and implementation in previous role(s).
Bachelors or Masters degree or equivalent in relevant biological science, healthcare discipline (medicine, pharmacy or nursing) or pharmacovigilance.
Bachelor’s degree in a healthcare discipline (i.e.: Life Science, Pharmacy, nursing or healthcare profession, or biomedical disciplines), Masters or advanced degree is desirable.
Experience in leading cross-functional projects within a global company is desirable but not required.
Minimum 7 years’ experience working in the healthcare industry and a strong understanding of the drug development process. Experience within Pharmacovigilance and Risk Management is desirable but not required.
Understanding of the tools, standards and approaches used to efficiently evaluate drug safety is desirable but not required.
Knowledge of the drug development process which includes: scientific strategy and operations, Regulatory requirements for submission, product launch and post marketing support.
Experience in working directly with and influencing senior management including functional heads.
Demonstrated effectiveness in working in multidisciplinary, matrix team situation and demonstrated ability to manage change.
Proven leadership and communication skills that minimally include: Effective and timely communication of project objectives, issues/risks as well as other project information required to keep the team and management informed.
Ability to adapt in a quickly changing environment, ability to engage team members across functions to facilitate information sharing in order to maintain a continuous flow of information; capability to clearly present, influence and logically justify positions/proposals; sound judgment; manages conflict and negotiation constructively; ability to develop build strong working relationships to enable high performing teams.