QPPV/Lead PhV Associate

Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose:

The purpose of the Qualified Person for Pharmacovigilance and Lead PHV Associate is to comply with the Lilly Pharmacovigilance requirements as well as Israeli Ministry of Health Regulations.

Primary Responsibilities:

Perform required PhV activities in line with local regulations and guideline

• Check Report Distribution Module regularly and perform expedited reporting (ensure correct submission/pulling of cases)
• Expedited reporting to Israel MOH
• Submission of new safety information and unusually frequent adverse events, as well as any other Pharmacovigilance activities as required by the regulation
• Submission of Periodic Safety Update Reports (PSURs/PBRERs) for registered products, as applicable.
• Submission of Development Safety Update Reports (DSURs), as applicable.
• Adheres to the applicable standards and procedures as well as the regulations.
• Submission of Risk Management Plan based on MOH guidelines No.142, effective date 01-Sep-2016

Receipt, initial review and entry of initial adverse event case reports and follow-up reports into LAM

• Serve as point of contact for receipt and collection of AE reports
• Adverse event case entry into the LSS Local Affiliate Module
• Ensure that all relevant information is captured and forwarded to Central within the designed 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
• Complete case follow-up as directed or required

Quality Control and Planning

• Perform quality checks on an ongoing basis: Monthly sample quality checks, metrics quality check, etc.

Market Research and Social Media

• Awareness and verification of the classification of the market research (Tier A, Tier B)
• Reconciliation of hidden adverse event in Social Media web page program

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 ensuring compliance with local regulatory requirements and GPS policies, procedures and processes
• Responsible for liaising with regulatory agency, work with Legal, Quality, Medical and Regulatory on safety issues if necessary
• Provide training and information for Lilly personnel and external parties in order to raise the awareness of Pharmacovigilance, if applicable.

Inspection reediness

• Responsible for inspection readiness activities.

Minimum Qualification Requirements:

• Education: Pharmacist or MD
• Basic computer skills (Microsoft Word, Excel, Windows)
• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills
• English language skills – written and verbal
• Approved as a QPPV, by the Israel MOH

Other Information/Additional Preferences:

• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills
• Strong knowledge of safety systems and process
• Knowledge of global regulations with respect to adverse event reporting
• Knowledge of MOH regulations
• LAM case manager
• Product Safety experience (>1year)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.