(Internship) Associate- Qualified Person for Pharmacovigilance - #16336
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Local Associate Qualified Person for Pharmacovigilance (QPPV) intern- Saudi Arabia
The purpose of the Local associate QPPV intern role is to be Lilly’s representative and point of contact for the local Ministry of Health (MoH)/ Regulatory Authority (SFDA)for all local pharmacovigilance (PhV) related matters in the absence of QPPV, the local Associate QPPV intern shall take up the key responsibilities described in this document.
General Responsibilities and Regulatory Compliance:
- Fulfil the legal and regulatory requirements for the QPPV responsible for pharmacovigilance role as defined by legislation and/or guidelines in the respective country(ies) of the region (i.e SFDA)
- Responsible for the establishment maintenance and oversight of Lilly’s local pharmacovigilance system, including the performance of the quality system and pharmacovigilance activities to promote, maintain and improve compliance with the legal requirements and relevant Good Vigilance Practice (GVP) requirements in the region.
- Understand the role of the Global and/or EU Qualified Person for Pharmacovigilance (QPPV) and assist as required.
- As necessary, ensure appropriate delegation of specific tasks to appropriately qualified and trained Global Patient Staff (GPS) and affiliate staff.
- As necessary, ensure appropriate backup coverage is in place in times of absence or unavailability.
- As necessary, ensure that any changes to the details of the Local QPPV are notified promptly to the MoH/SFDA and the Global QPPV and or EU QPPV Monitor national pharmacovigilance legislation.
- Ensure appropriate interpretation and implementation of national pharmacovigilance legislation/regulation.
- Responsible for liaising with MoH/SFDA work with legal, quality, medical, and regulatory on safety issues if necessary.
- Responsible for appropriate communication between local safety team, Global Patient Safety (GPS), Global and/or EU QPPV and other relevant stakeholders (product complaints, medical, and regulatory affairs) to ensure compliance with safety obligations.
- Responsible for understanding and meeting local reporting requirements.
- Ensure and verify that the information contained in Lilly’s European Pharmacovigilance System Master File (EU PSMF) and associated country documents are maintained as applicable.
- Has awareness and provides input to local Risk Management Plans, local risk minimization activities and local Post Safety Authorization Studies as applicable.
- Interact and escalate as necessary safety issues with MoH/SFDA and GPS.
- Ensure local business alliance and third-party safety agreements are in place, up to date and followed as required.
- Ensure customer facing affiliate employees and third parties are trained on adverse event reporting.
- Ensures periodic reports are submitted as applicable.
- Provide training for Lilly personnel to raise the awareness of Pharmacovigilance, where applicable.
- Provide Pharmacovigilance information to external customers (e.g. third parties)
Adverse Event (AE) Management Responsibilities:
- Serve as point of contact for reception and collection of AE reports.
- Adverse event case entry into the safety database.
- Perform and document initial case assessment (seriousness, causality, and expectedness) for all cases received locally.
- Ensure that all relevant information is captured and forwarded to GPS within the designated timeframe, both for initial and follow-up reports.
- Responsible for the accuracy and completeness of information reported from clinical trial, post marketing surveillance study and spontaneous adverse events for marketed products and devices, as applicable.
- Complete case follow-up as directed or required.
- Responsible for generating and submission of the necessary case reports that are required for expedited reporting to the MoH/SFDA.
- Reconciliate case reports with business partners, medical information, and product quality.
- Archive case source documentation.
Standards and Inspection Readiness:
- Strive for inspection and audit readiness and participate in aligned affiliate inspections, audits, and assessments. Act as point of contact when required.
- Ensure relevant safety standard operating procedures (SOP) are well understood across the affiliate; lead and provide clarification on local implementation where applicable.
- Support the development of global SOPs to ensure alignment with local laws and regulations.
- Help to interpret relevant regulations and guidelines and acts as a contact person in the affiliate.
- Responsible for ensuring compliance with MoH/SFDA requirements and GPS policies, procedures, and processes.
Minimum Qualification Requirements:
- Bachelor's degree in pharmacy, PharmD or Medicine.
Other Information/Additional Preferences:
- Knowledge and understanding of local, regional and global procedures as applicable.
- Knowledge of legislation with regards to relevant national regulatory guidelines, directives, and regulations in Pharmacovigilance.
- Knowledge of quality systems.
- Graduates with first class honors from top universities
- Excellent communication (written and verbal) in English and Arabic, interpersonal skills.
- Strong Organization & Planning
- Ability to work under pressure.
- Flexible with diverse dynamic demands
- Ability to work independently and with a team.
- Professional knowledge of English including medical terminology
Other roles requirements:
- May require evening work / weekends.
- The role is based in Riyadh office (onsite)
- Must be legally allowed to work in KSA.
- Internship duration is 1 year.
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