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Pharmacovigilance (Dutch OR French Speaking)

Posted on Sep 10, 2020 by Parallel Consulting

Amsterdam, Noord-Holland, Netherlands
Research
Immediate Start
Annual Salary
Contract/Project


Job Title Affiliate Pharmacovigilance Associate


Reporting To Team Lead


Summary


- 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.


Submissions:


- 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


Areas


MEASURABLE:


- 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


NON-MEASURABLE:


- 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


Qualification


- 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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