Qualified Person for Pharmacovigilance (QPPV)

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the world. We are a global healthcare leader headquartered in Indianapolis,
Indiana. Our ‎35,000 employees around the world work to discover and bring
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first. We're looking for people who are determined to make life better for
people around the world.
Job Summary:
The role of the Qualified Person Responsible for Pharmacovigilance (QPPV) is
to be the
point of contact for the Saudi FDA , ministry of health (MOH) and other
governmental entities for all related pharmacovigilance (PV) matters. This
includes and not limited to adverse event and device reports; ensure
regulatory
compliance for expedited and periodic submission of safety reports;
collaborate with internal and external customers; provide support to global
personnel regarding Global Patient Safety (GPS) policies, processes and
procedures.
Path/Level:
P1
Note: Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.)
transfer at their current level, despite the level indicated on the job
posting. For example, if a P2 candidate is selected for a P1-P3 banded
position, the candidate will remain a P2 in the new role.
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 Local SFDA guidance.
* 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
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/ local affiliate module (LAM)
* 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 SFDA.
* Reconciliate case reports with business partners, medical information, and product quality.
* Archive case source documentation.
* Check LSS Report Distribution Module regularly and perform expedited reporting (ensure correct submission/pulling of cases)
* Submission of Periodic Safety Update Reports (PSURs/PBRERs) for registered products, as applicable.
* Adheres to the applicable standards and procedures as well as the regulations
* The QPPV is the master authorization holder (MAH )contact point for pharmacovigilance inspections or should be made aware by the MAH any inspection, to be available as necessary.
* Perform quality checks on an ongoing basis: Monthly case quality checks, metrics quality check, etc.
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/RA(s)requirements and GPS policies, procedures, and processes
* Perform quality checks on an ongoing basis: Monthly case quality checks, metrics quality
* check, etc.
Responsible for optimizing the value of Lilly products through the promotion
of patient safety
* Responsible for basic understanding of Adverse Event management and workflow elements
* Responsible for appropriate communications between Pharmacovigilance locally and Central, and with product complaint organization, medical and regulatory affairs
* Responsible for liaising with regulatory agency, work with Legal, Quality, Medical and Regulatory on safety issues, if necessary
* Provide training for Lilly personnel to raise the awareness of Pharmacovigilance, where applicable.
* Provide Pharmacovigilance information to external customers (e.g. third parties)
Professional Development:
* Keep up dated on trainings for professional development
* Ensure performance objectives are completed in line with company process
* Understanding of all company policies and procedures
Educational Qualifications:
* Pharmacist or physician
Knowledge and Experience:
Core:
* Minimum ‎1 year in pharmaceutical or healthcare industries
* Knowledge of local law and international guidelines regarding drug safety and CMC regulatory requirements
Desirable:
* Previous QPPV or QPPV deputy role
* Previous SFDA related QPPV training courses
Skills:
* Excellent communication (written and verbal) in English and Arabic, interpersonal skills
* Strong Organization & Planning
* Strong knowledge of quality systems
* Ability to work under pressure
* Flexible with diverse dynamic demands
* Ability to work independently and with a team

Other Role Requirements:
* Saudi Nationals only
* May require both domestic and international travel
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(collectively "Lilly") are committed to help individuals with disabilities to
participate in the workforce and ensure equal opportunity to compete for jobs.
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