Pharmacovigilance (Dutch OR French Speaking)
Posted on Sep 10, 2020 by Parallel Consulting
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.
- 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
- 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
- Achievement orientation
- Relationship building ability
- Interface with other departments
- Personal grooming and etiquette
- 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.