OneMain Financial Jobs

About the Role

We are looking for a dedicated and detail-oriented Affiliate Pharmacovigilance Associate to join our growing team in the Netherlands. In this role, you will be responsible for supporting pharmacovigilance operations, including case receipt, data entry, literature search and review, and adverse event reconciliation — all in line with client standards and applicable regulatory requirements.

Responsibilities

Case Receipt:

• Responsible for receiving all information (including source documents) submitted by Reporters via any Intake Method approved by client

• Translate source documents from Non-English to English (and vice versa if required) and update relevant fields in AE form (if applicable)

• Translate source documents from Non-English to English using client provided translation tool and update any changes in the translation tool’s segments/ source documents

• In accordance with client policies and standards, check for case validity and identify & determine, whether information received from Reporters is a duplicate, includes any Adverse Events (AE), Product Quality Complaints (PQC), Device Complaints and/or Medical Information Inquiry content

• Check the information received from Reporters contains a Product Quality Complaint, Device Complaint and/or Medical Information Inquiry, send to the appropriate party(ies) appointed by client

• Auto-Acknowledge receipt of all information submitted by Reporters. Manual acknowledgement may be required on a minimal number of exception cases

• Enter source document information (AE & PQC) in front-end system and evaluate the safety information for case seriousness and including potential for upgrade /downgrade of follow up (FU) cases

• Monitor mailbox, triage safety reports and emails

• Maintain and archive emails/source documents for any missing/discrepant safety information and update Share Drive/folders

• Ensure up front clarification requests in case of data discrepancy identified insource documents

• Identify discrepancies and maintain email clarifications of discrepancies for Source Data Verification (SDV)

• Perform Health Authority database extraction to retrieve ICSRs which are directly submitted to Health Authority

• Perform FU Queries using the relevant letter, track FU attempts until closure

• Responsible for completion of day-to-day work and process flows within the agreed Service Level Agreements (SLAs)

• Attend training sessions and develop skills and capabilities on an ongoing basis

• Timely completion of assigned trainings and training files

• Assists in the training and mentorship of new joiners as necessary

• Co-ordinate with internal teams to obtain necessary information required for day to-day operations

• Responsible for completion of any additional tasks/ activities as per project needs

Literature Search and Review:

• Search for publication title in client search engine and download the publication

• Sending/Receiving publication article for translation if required

• Determine case reportability and report (if applicable)

• Assess for valid literature report on the basis of validation criteria

• Translate document in English

• Responsible for updating and maintaining the literature tracker for case tracking

• Submit the case for intake process, follow up with author for additional information

• Entering the literature case in database with information

• Document review process

• Analyze potential impact of benefit risk profile

Ancillary Activities:

• Perform AE reconciliation and track in reconciliation tracker.

• Maintain reconciliation records in the Share drive folder.

• Run reports from client database and reconcile with reconciliation report.

• Identify discrepancies and maintain email clarifications of discrepancies, file reconciliation documentation.

• Maintain complete reconciliation records for each partner and update the reconciliation status in the relevant calendar

• MRP program closeout: ensure all safety data collection activities have been completed; conduct final reconciliation.

• Perform quarterly after-hours testing.

• Available after hours to support the project for operational coverage.

• Maintain data as per the customer guidelines.

• Attend training sessions and develop desired skills and capabilities on an ongoing basis

• Willingness to assist team leads or take up ad-hoc operational activities as required

Requirements

• Graduate in Life Science or Pharmacy

• Good verbal and written communication skills

• Fluent in Dutch and English

• Ability to prioritize work

• Service excellence oriented

• Proactive Team Player

• Analytical and Problem-solving capabilities

• Attention to detail

• Computer Literate

What we offer:

• A competitive salary based on your qualities and experience

• NS business card to cover your commute expenses

• 25 days of paid holiday per year

• A laptop and a smartphone

• A pension scheme

• Health insurance

• Organization driven by technology – we have a tremendous technology backbone

• Access to Udemy, Cognizant Academy digital libraries for your continuous learning

• Open, ‘can do’ team spirit and international environment that encourages making your ideas reality!

Diversity and Inclusion at Cognizant

At Cognizant, we believe diversity and inclusion are at the heart of our ability to execute successfully and consistently over the long term. We recognize that our people are our most important asset. We strive to create an environment where all associates feel comfortable to be themselves, feel accepted and can therefore thrive both personally and professionally. We continue to drive D&I throughout our organization to unlock the insights, imagination and innovation of our associates, as well as reflect the diversity of our clients and communities. We are a Dutch and European Top Employer and continually drive employment recognition and engagement through employee friendly policies and affinity groups such as “Women Empowered”, “Embrace LGBTQ+” and “Race Equality Network”. For more information, see https://careers.cognizant.com/global/en/diversity-and-inclusion.

Recruiter contact details

Name: Nikoletta Katona

Email: nikoletta.katona@cognizant.com

Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.