ICSR Liaison Manager
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V., we are searching for an ICSR Liaison Manager.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people world-wide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
As ICSR Management Liaison Manager, you are responsible for development and maintenance of excellence in Regional PV Process ICSR Management Interface. You are the key contact for routine interactions with License Partners regarding operational activities described in safety data exchange agreements (SDEAs), as well as for Astellas-internal functions requiring regular interactions with PV Process.
Responsible for regulatory compliance of regional (out sourced) activities. You will work extensively with PV process staff within the region as well as with regional or assigned global license partners and Astellas Global Development Organisation, 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 Astellas 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 organised data collection programs 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
- Represent Regional PV Process in Inspections, PV audits and non-PV audits (GCP) as requested;
- Oversee Regulatory compliance and QC of out sourced activities and implement business regulatory compliance and inspection readiness requirements in co-operation with regional PV Process assigned license partners.
Vendor & Partner Management:
- Support operational vendor management of regional vendors to maximise 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 organisation and other Astellas functions, License Partners and the vendor(s)
- Oversee the compliance of License Partner-related activities and ensures Corrective and Action Preventive Actions (CAPAs) are implemented in case of non-compliance;
- Responsible for timely escalation in case of compliance issues;
- Ensure adherence to regional regulatory obligations and alignment with global processes in tight co-operation with the Business Partner Maintenance team;
- Involved in ensuring regional vendor compliance to contract terms.
- Ensure major projects are completed as scheduled, within budget and with high quality. Ability to identify and initiate process improvements. Assignments and projects are often self -initiated. Interpret, execute and recommend changes to established policies and programs. Failure to achievement results could result in a failure to achieve organisational objectives.
People & Organisation Management
- Deputises for the team leader as needed;
- Responsible for the development and maintenance of effective collaborations with peers in Global PV Process Vendor Management and internal GPV key stake holders and functions;
- Support the execution of the GPV operational strategy, supporting the overall GPV mission;
- Work extensively with relevant internal and external stake holders, particularly with Business Partner Management for license partner communication and SDEA contents.
Who we're looking for
The ideal candidate has:
- Minimum BA/BS in life sciences;
- 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;
- In-depth knowledge of pharmacovigilance processes and operations, including out sourcing and vendor management;
- Proven experience with (GxP) Qualities Management System;
- In-depth understanding of PV, data management and adverse event reporting and processing;
- Able and willing to travel as required;
- Decision making skills;
- Negotiation skills;
- Excellent interpersonal skills.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least 1 year.
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555