JobSearchGulf

Pharmacovigilance ? Associate- Pakistan - Jobs in Pakistan

1.00 to 10.00 Years   Pakistan   25 Nov, 2022
Job LocationPakistan
EducationNot Mentioned
SalaryNot Mentioned
IndustryOther Business Support Services
Functional AreaNot Mentioned

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 35,000 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 Local QPPV/LSR/CPPV role is to be Lilly?s representative and point of contact for the local Ministry ofHealth (MoH)/ Regulatory Authority (RA)for all local pharmacovigilance (PhV) related matters. In the absence ofQPPV/LSR/CPPV, the local Deputy QPPV or LSR/CPPV delegate (as applicable) shall take up the key responsibilitiesdescribed in this document. The exact role name can vary depending on local regulatory and or human resource (HR)requirements.For the purposes of this document we will use the term Local QPPV and Local Deputy QPPV. All references to Local QPPVincludes the Deputy Local QPPV or LSR/CPPV delegate and are represented as QPPV in this document.Primary Responsibilities: This job description is intended to provide a general overview of the job requirements atthe time it was prepared. The job requirements of any position may change over time and may include additionalresponsibilities not specifically described in the job description. Consult with your supervision regarding your actual jobresponsibilities and any related duties that may be required for the position.1. General Responsibilities and Regulatory Compliance:? Fulfil the legal and regulatory requirements for the QPPV responsible for pharmacovigilance role as defined bylegislation and/or guidelines in the respective country(ies) of the region.? Responsible for the establishment maintenance and oversight of Lilly?s local pharmacovigilance system, including theperformance of the quality system and pharmacovigilance activities to promote, maintain and improve compliance withthe 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/RA and theGlobal QPPV and or EU QPPV Monitor national pharmacovigilance legislation.? Ensure appropriate interpretation and implementation of national pharmacovigilance legislation/regulation.? Responsible for liaising with MoH/RA, 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 EUQPPV and other relevant stakeholders (product complaints, medical, and regulatory affairs) to ensure compliance withsafety 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 PostSafety Authorization Studies as applicable.? Interact and escalate as necessary safety issues with MoH/RA 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.2. 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.? Ensure that all relevant information is captured and forwarded to GPS within the designated timeframe, both for initialand follow-up reports.? Responsible for the accuracy and completeness of information reported from clinical trial, post marketing surveillancestudy 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 tothe MoH/RA.? Reconciliate case reports with business partners, medical information, and product quality.? Archive case source documentation.3. Standards and Inspection Readiness:? Strive for inspection and audit readiness and participate in aligned affiliate inspections, audits, and assessments. Act aspoint of contact when required.? Ensure relevant safety standard operating procedures (SOP) are well understood across the affiliate; lead and provideclarification 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.Minimum Qualification Requirements:? Minimum requirements as defined by legislation or Bachelor degree in a health profession (i.e. Pharmacy, Nursing) or lifescience field or equivalent demonstrated experience in patient safety.? Knowledge and understanding of local, regional and global procedures as applicable.? Knowledge of legislation with regards to relevant national regulatory guidelines, directives and regulations inPharmacovigilance.Other Information/Additional Preferences:? Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.? Strong knowledge of quality systems.? Professional knowledge of English & Urdu including medical terminologyEli 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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.#WeAreLilly

Keyskills :

APPLY NOW

© 2020 JobSearchGulf All Rights Reserved