Responsible for development and maintenance of excellence in Regional PV Process ICSR Management Interface. Reports to the Lead Regional PV Process ICSR Management Interface, and contributes to the successful execution of the GPV objectives and 1-3 year operational plan, supporting the overall GPV mission.
This function is the key contact for for routine interactions with License Partners regarding operational activities described in safety data exchange agreements (SDEAs), as well as for the company functions requiring regular interactions with PV Process.
Responsible for regulatory compliance of regional (outsourced) activities. Works extensively with PV process staff within the region as well as with regional or assigned global license partners an the organization, Medical Affairs and local Drug Safety Officers to ensure alignment with GPV’s vision and that these interactions directly support the ongoing assurance of the safety profile of the products.
The ICSR Management Liaison Manager is responsible for:
Ensure PV requirements are incorporated in protocol design for interventional as well as non-interventional studies and Market Research Programs and/or Safety Management Plans for clinical studies or organized data collection progrems conducted in (assigned) region
Build and maintain close relationships with DSOs, Regulatory Affairs, Clinical and Medical Affairs functions in assigned region
Product Quality Complaint Management:
Build and maintain close relationships with QA, Regulatory Affairs, Product Supply and Manufacturing functions in assigned region
Responsible for operational execution of Product Quality Complaint processing and evaluation in assigned region (Triage, Forwarding, Investigation, Reconciliation and Reporting)
Quality, Data Assurance & Business Information management
Represents Regional PV Process in Inspections, PV audits and non-PV audits (GCP) as requested.
Oversee Regulatory compliance and QC of outsourced activities and implement business regulatory compliance and inspection readiness requirements in cooperation with regional PV Process assigned license partners
Vendor & Partner Management:
Supports operational vendor management of regional vendors to maximize the quality, compliance and (cost)
effectiveness of the work team outputs.
Manage periodic interactions with License Partner(s) according to the SDEA(s) as required for Operational activities that are either delegated to the License Partner or performed by Astellas (or its vendor(s)) on behalf of the License Partner
Build and maintain collaborative relationships with regional or assigned global license or co-developmental partners and vendors. Contribute to joint development of strategies to continuously improve deliverable quality.
Serve as liaison between the regional PV Process organization and other Astellas functions, License Partners and the vendor(s)
Oversees the compliance of License Partner-related activities and ensures Corrective and Action Preventive
Actions (CAPAs) are implemented in case of non-compliance.
Reponsible for timely escalation in case of compliance issues.
Ensure adherence to regional regulatory obligations and alignment with global processes in tight cooperation with the Business Partner Maintenance team
Involved in ensuring regional vendor compliance to contract terms.
Ensures major projects are completed as scheduled, within budget and with high quality. Ability to indentify and initiate process improvements. Assignments and projects are often self -initiated. Interprets, executes and recommends changes to established policies and programs. Failure to achievement results could result in a failure to achieve organizational objectives.
People & Organization Management
Deputizes for the team leader as needed.
Responsible for the development and maintenance of effective collaborations with peers in Global PV Process
What we offer
What we offer
Good salary (5000-6000)
A fulltime (40 hours) job
A project for a year
Minimum BA/BS in life sciences
Living in the Netherlands
Minimum of 5 years relevant experience in the pharmacovigilance or combined PV/RA/QA, and/or clinical development
In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations
In-depth knowledge and understanding of PV Process regulatory requirements and guidelines in assigned region
Proven experience with (GxP) Qualities Management System.
In-depth understanding of PV, data management and adverse event reporting and processing.
Skills and competencies:
Demonstrates effective leadership to ensure interactions and compliance are maintained at highest standards at all times
Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration.
Demonstrated ability to proactively predict and resolve complex problems and/or conflict situations, think strategically and tactically, generate solutions to complex problems and build consensus in interaction with other functions within or outside the organization. Able to generate insights and leverage learnings at the individual and team level.
In-depth knowledge of pharmacovigilance processes and operations, including outsourcing and vendor management
Experience with global responsibilities for safety projects
Able to lead meetings, present orally and interact with external bodies
Excellent communication and presentation skills in English (written and spoken)
Ability to leverage all available resources internally and externally
Able and willing to travel as required
Able to determine best course of action based on strategic direction
Decision making skills
Independent working – plans, schedules and arranges own activities to achieve desired results
Independently manages projects that span across various functions or departments
Consults with senior management on a regular basis.
Has a strong sense of urgency and compliance
Previous relevant experience in CROs and/or other pharma companies
The location for this position is in the assigned region: Leiden, The Netherlands
Demonstrated experience in cooperation with license partners
About the company
About the company
The company is located in Leiden. If you come by car you can park on the premises of the company. It is also easily accessible by public transport. You can easily get there from The Hague, Amsterdam (Schiphol), Utrecht and Rotterdam.
The company is incredibly large in the pharmaceutical industry. They develop and make medication and do research.