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Pharmacovigilance (Dutch OR French Speaking)

Posted on Sep 10, 2020 by Parallel Consulting

Amsterdam, Noord-Holland, Netherlands
Immediate Start
Annual Salary

Job Title Affiliate Pharmacovigilance Associate

Reporting To Team Lead


- Responsible for receiving/Downloading information from Email/SharePoint, receiving call for Adverse Event, Medical inquiry (MI), Product complaint (PC), Other inquiry (OI).

- Route information/safety reports to appropriate Department viz. Medical inquiry (MI), Product complaint (PC), Other inquiry (OI).

- Monitoring mailbox, triage for patient safety reports and emails.

- Maintaining and archival of emails/source documents and updating SharePoint/folder.

- Handling of source document and entering data in client tracking system as per triage criteria. Acknowledge receipt of information as defined by client.

- Obtain consent from reporter for follow up report.

- Assess cases for missing information and initiate Follow up Query Letter using the proper letter format and tracking the follow up attempts till the closure of follow up.

- Check Case Validity as defined by client.

- Perform initial checks, search database to prevent duplicate entries.

- Ensure that upfront clarification requested in case of data discrepancy in source document.

- Enter safety information in client system and evaluating the safety information for case seriousness and potential upgrade and downgrade for seriousness in follow up cases, evaluate dechallenge-rechallenge.

- Patient Support Program - Source Data Verification (SDV); obtain reports from vendor and reconcile data with client application.

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

- Translation & Back Translation of patient safety reports within the client SLA.

Literature search & 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 (as applicable).

- Assess for valid literature report on the basis of validation criteria.

- Translate document in French

- 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.


- Perform submission to regulatory authority, investigator, ethics committee

- Check for Country specific criteria for submission.

- Verify source document and database before submission.

- Responsible for updating and maintaining the tracker for case submission and acknowledgment.

- Check case type and assess cases for submission as per local and global regulatory guidelines. Update client tracking system regarding submissions details, generate CIOMS and relevant forms to be completed.

- Back translation in local language, complete the distribution records in ARISg,

- Archive submission reports and acknowledgement.

- Monitor errors for submission and rectify the same.

- Responsible for completion of day-to-day work and process flows within the agreed service levels (SLAs)

- Maintaining the data as per the customer guidelines.

- Work with quality person to improve the case quality.

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

- Timely completion of assigned trainings and the training files.

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

- Assists in the training and mentorship of new joiners as necessary.

Ancillary Activities:

- Organized Data Collection Adverse Event Reconciliation. Enter data in reconciliation tracker.

- Maintain reconciliation records in the SharePoint folder.

- Running report/s from client database and reconcile with vendor report.

- Identify discrepancy/ies and maintain email clarifications of discrepancies.

- Maintain complete reconciliation records for each vendor and update the reconciliation status within SLA.

- PSP/MRP Program Closeout: to ensure all PV requirements have been completed including adverse event reporting, reconciliation and document retention.

- PMOS AE reconciliation: create and maintain documentation, resolve mismatches and file reconciliation documentation.

- Internal Adverse Event Reconciliation: (Medical inquiry (MI)/Product quality complaint (PQC) create and maintain documentation, resolve mismatches and file reconciliation documentation.

- Quality review data as defined in Quality control plan.

- Review entry of source document information in client database and document the feedback in a quality tracker and maintain the quality data for each case. Providing feedback.

- Analyze common defect and defect trend to maintain the appropriate quality.

Elevate the common defects to training team and leads

Key Result



- Establish systems and procedures in the team

- Quality audits for grooming and service delivery

- Zero error

- Customer satisfaction index

- Employee motivational index

- Punctuality and self-discipline

- Inter personal effectiveness


- Self-motivation

- Achievement orientation

- Relationship building ability

- Interface with other departments

- Personal grooming and etiquette

- Punctuality

- Inclination towards being process driven

- Going out of the way to satisfy the external customer


- Graduate in Pharmacy or Life-Science

- Strong preference of 1 year of Pharmacovigilance or relevant Clinical experience

- Excellent spoken and written English proficiency (level B2 CEFR minimum or equivalent preferred) or education in English medium OR

- Certified translators by a recognized school (for translating Non-English language into English etc )

Parallel Consulting is acting as an Employment Business in relation to this vacancy.

Reference: 945762970

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