Data Assurance Associate fulltime Leiden

Olympia - Leiden

2500-3500
WO/Universitair
40 uur

Functieomschrijving

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.

Main tasks:

  • 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
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 activitiess
  • Responsible for the development and maintenance of effective collaborations with internal GPV stakeholders and functions, as well as of relevant external stakeholders:

Functie-eisen

Job requirements:

  • 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,
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 Astellas' 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.

Arbeidsvoorwaarden

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.


Sollicitatieprocedure

Olympia - Waarom bij ons werken?

Bedrijfsinfo
Website
Ga naar website
Locaties
Den Haag
Aantal medewerkers
1000+
Jaar van oprichting
1969
Branche
Uitzend/detachering/W&S
Internationaal actief
Nee
Omzet
> 100.000.000
Vacature contactpersoon Olympia

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Data Assurance Associate fulltime Leiden

Solliciteer via Bedrijf
Zet in favorieten
Bedrijfsinfo
Ga naar website
Den Haag
1000+
1969
Uitzend/detachering/W&S
Nee
> 100.000.000

Vacature info