Purpose & Scope: Summarize the major purpose of the job in 1-3 fulltime sentences. Intent is to capture what this job does for our company, why the role exists. Not a summary of duties.
Responsible for aspects of excellence in Regional PV Process Distribution & Submissions. Reports to the Lead Regional PV Process Distribution & Submissions and contributes to the successful execution of the GPV objectives and 1 -3 year operational plan, supporting the overall GPV mission.
Works extensively with PV Information Management within the region to ensure the quality of outputs as well as system configuration to strengthen the correct functioning of the companies PV System supporting the ongoing assurance of the safety profile of the products. Acts as a liaison between the teams to translate business requirements into system configuration.
Essential Job Responsibilities: List 10 or fewer primary duties and responsibilities for this position in order of importance and time spent. Include supervisory responsibilities. Focus on responsibilities rather than projects. Avoid being vague or listing many minor duties.
Strategy Development and Execution:
Responsible for implementing, maintaining and improving tools to ensure compliance with regulatory reporting responsibilities (ICSRs as well as other safety reports) and to ensure high quality supporting documentation.
Contributes to the successful implementation of annual Regional PV Process Management strategic goals and objectives.
The PV Process Configuration Manager is responsible for:
Compilation and technical implementation of all regulatory requirements and guidelines from region Leiden
Maintains up-to-date oversight and knowledge of all regulatory reporting requirements to Competent Authorities in the region (EMEA: over 100 countries; JP/Asia: appr. 10-20 countries; Americas: appr. 10 countries); Liaises with Global PV Process and line management to explore and identify the possible impact of any new or revised regulations
Maintains up-to-date and complete oversight of regulatory reporting rules and complete oversight of our product information and status in assigned region
Verifies regional implementation and maintenance of Business Partner/SDEA specific submission/exchange requirements
Build and maintain close relationships with Global PV Information Management.
Quality, Data Assurance & Business Information management:
Executes reporting compliance QC measures at the regional level to ensure correct technical implementation of ICSR reporting requirements
May represent the Regional PV Process Distribution & Submissions team in Inspections and PV audits.
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position. Tijdelijk dienstverband
Employees holding this position may perform other job-related duties in the course of their performance of this position.
Generates and maintains user requirements for Argus reports and listings, periodic as well as ad hoc. Responsible for QC of such outputs. (As applicable: Serves as a global Center of Excellence for ICSR-related Argus outputs).
Responsible for PV Process administrative system user management of regional staff in tight cooperation with the regional PV Process Governance function to ensure training requirements are met.
People & Organization Management
Responsible for the development and maintenance of effective collaborations with peers in Regional PV process and internal GPV key stakeholders and functions, as well as of relevant external stakeholders:
With Regional Affiliate Management as well as Global PV Operations for the collection and collation of regional regul
Skills and competencies:
Demonstrates a quality mindset and attention to detail to execute QC measures ensuring case submission and compliance are maintained at highest standards at all times
Strong interpersonal skills; able to negotiate and build consensus and able to develop effective relationships through collaboration.
Demonstrated ability to think strategically and tactically and generate solutions to complex problems. Able to generate insights and leverage learnings at the individual, team and functional level.
Able to lead meetings, present orally and interact with internal stakeholders
Strong working knowledge of and experience with the management of complex global IT systems.
Living in The Netherlands
Very good in English language (speak and writen)
Minimum BA/BS, preferably with an advanced professional degree
Minimum of 5 years relevant experience in the pharmacovigilance or combined PV/RA/QA, and/or clinical development
In-depth knowledge and understanding of PV Process regulatory reporting requirements and guidelines in assigned region
In-depth understanding of PV, data management and adverse event reporting.
Experience in managing multiple projects in a heavily matrixed and/or cross-functional environment
Previous relevant experience in regulatory authorities
Previous experience with E2B generation, modification, import and acknowledgement tracking is a plus
Previous experience in Argus administration or in SQL programming is a plus
The location for this position is in the assigned region: Leiden, The Netherlands
What we offer
Fulltime job in an international environment;
Good working conditions;
Salary: € 5.000,- - € 6.000,- (based on working experience);
About the company
Europe is a global centre of excellence in healthcare and the company is committed to supporting EMEA by working in partnership with local governments to ensure patients can benefit from our medicines.
The EMEA headquarters of our company brings the specialist knowledge required to ensure our research programmes and medicines meet the requirements of individual countries in which doctors and patients live – as well as the medical and regulatory organisations that support them.
Our hope is to change tomorrow. To improve the lives of men, women and children by providing innovative medicines in areas of health where there is urgent need for better treatments. Transplant recipients, patients fighting cancer, those with life-threatening infections – these are just some of the patients we are striving to help now and in the future through our single-minded focus on turning innovative science into medical solutions.
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