For Astellas in Leiden we are looking for a fulltime data assurance associate for the period of six months.
In this role you are responsible for maintenance of excellence in Pharmacovigilance Process Data Assurance/ Medical Consistency.
- Operational execution of ICSR processing and evaluation in assigned region (Data collection, Triage, Translation, Data entry, MedDRA coding, Case Assessment & Medical Evaluation, and Follow-up) in line with global ICSR case processing policies and strategies.
- First line of decision making on case processing matters for priortization, FU significance, seriousness, listedness, coding queries, etc.
- Responsibility for performing or initiating case corrections as needed, and for deciding on the type of corrections required.
- Performing SME services for ICSR processing queries by the vendor / internal case processing staff.
- Ensure and maintain excellence, consistency, completeness, and accuracy in case processing within region by performing quality control for outsourced activities
- Collaborate with global vendor managers to ensure capacity management of global case flow in order to maintain critical business continuity in all circumstances
- Responsible for backup and support of Global Vendor Management workflow managers to ensure 24 h coverage and business continuity of workflow management
- Supports late case investigations by the regional PV Process Governance team.
- Oversees triage, review and processing of Individual Literature Case Reports in assigned region
- Provide PV Process support to PV Process Global Management in PQC processing in the global safety database
- Implement global QC policies and strategies at the regional level
- Responsible for operational execution of QC of ICSRs, including at vendor level in assigned region
- May represent Regional PV Process in Inspections, PV audits and non-PV audits (GMP/GCP) as an SME on case quality matters.
- Support the Regional PV Process Data Assurance/Medical Consistency Lead by reviewing procedural correctness of decision-making on and execution of study-case unblinding (SUSAR unblinding as well as end-of
- Serves as liaison with regional DSOs on ICSR matters and ensures appropriate information flow (ICSR
- Cooperate with the colleagues in the other regions to ensure consistency in QC execution.
- Acts as regional SME on case processing in general, provides advice and guidance, and answers relevant queries as appropriate.
- Responsible for training (PV Processes and Systems) of Vendor and PV Process staff in assigned region
- Providing specialist education to PV and non-PV staff and vendor staff performing PV process activitiess
- Responsible for the development and maintenance of effective collaborations with internal GPV stakeholders and functions, as well as of relevant external stakeholders:
- BSc/MSc degree in life sciences or equivalent
- At least 3+ years relevant experience
- In-depth knowledge and understanding of PV Process regulatory requirements and ICSR processing procedures globally and in assigned region
- A technical expert within the organization, with extensive knowledge within their chosen specialty and developing knowledge of related disciplines. Has the ability to recommend enhancements to internal policies,
- Provides solutions to a wide variety of problems of greater complexity that require the regular use of creativity and ingenuity, while safeguarding Astellas' compliance.
- Ensures case processing and case quality are maintained at highest standards at all times
- Strong interpersonal skills and multi-cultural /intercultural awareness; able to develop effective relationships through collaboration.
- Good communication skills in English (written and spoken)
- Ability to work independently. Work is reviewed from a relatively long-term perspective, towards predetermined long-range goals and objectives.
We offer a challenging and responsible fulltime position with a projectcontract for 6 months, with possible extension.
Salary based on experience between €2500 - 2900,- based on fulltime.