Responsible for maintenance of excellence in Regional PV Process Data Assurance/Medical Consistency. Reports to the Regional PV Process Data Assurance/Medical Consistency Lead and contributes to the implementation, and successful execution of the GPV objectives, supporting the overall GPV mission. Responsible for ensuring the quality of contracted work delivered under the GPV Process Management office. Responsible for execution of all in-house case processing activities on time and with high quality to ensure compliance with regulatory requirements and the company policies. Works extensively with vendor personnel and PV process staff within the region to ensure the high data quality required to support the ongoing assurance of the safety profile of the company products and the company compliance.
Essential Job Responsibilities:
Strategy Development and Execution
Responsible for implementation and execution of various QC measures in ICSR processing. Contributes to the successful implementation of annual Regional PV Process Management goals and objectives;
The Data Assurance Associate Senior Officer is responsible for communicating with internal (particularly DSOs, PRPs, Quality Organization) and external (Regulatory Authorities, vendor) parties on case contents, and to reply to related queries;
Responsible for day-to-day maintenance of the EU safety mailbox.
The Data Assurance Associate Senior Officer is responsible for:
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;
Readiness to perform case processing in a business continuity situation;
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.
Product Quality Complaint Management:
Provide PV Process support to PV Process Global Management in PQC processing in the global safety database.
Quality, Data Assurance & Business Information Management
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 study unblinding);
Serves as liaison with regional DSOs on ICSR matters and ensures appropriate information flow (ICSR collection, outbound FUs etc.) and quality thereof;
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.
What we offer
What we offer
Good salary (5700-7200) based on experience;
Full time project (40 hours) for 4 months.
MS degree in life sciences or equivalent;
5+ 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, processes and procedures based on new requirements, legislation, etc;
Provides solutions to a wide variety of problems of greater complexity that require the regular use of creativity and ingenuity, while safeguarding the company compliance;
Skills and competencies:
Living in the Netherlands;
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 and Dutch (written and spoken);
Ability to work independently. Work is reviewed from a relatively long-term perspective, towards predetermined long-range goals and objectives.
About the company
About the company
The company is easily accessible by public transport from Rotterdam, The Hague, Amsterdam (Schiphol) and Leiden. Also it is possible to come by car they have a large number of parking spaces at the company.