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Senior Data Assurance Officer

Solliciteer direct
Uren per week
40 uur

Over de functie

Over de functie

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:
ICSR Processing:
 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.

Literature Management:
 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.

 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 activities
 Keep abreast of relevant procedures to maintain knowledge of case processing activities

Vendor Management:
 Manages assigned projects related to process improvements regarding case processing activities

People & Organization Management
 People & Organization Management
 Perform activities directly contributing to and impacting Regional PV Process Management goals .
 Responsible for the development and maintenance of effective collaborations with internal GPV stakeholders and functions, as well as of relevant external stakeholders:

  • With

Wat we bieden

We offer you a fulltime job in an international environment. Also good working conditions and the ability to work from home!

Salary: 3000-4200 based on working experience.

Functie eisen

 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 the company safeguarding compliance.

Skills and competencies:
 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.

Over het bedrijf

This international pharmaceutical company is located all over the world, this job is recuired in Leiden. It turns innovative science into value for patients.


COVID-19 Update: solliciteren kan nog steeds, je gesprek kan digitaal plaatsvinden.

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Schipholweg 55
2316 ZL Leiden

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