Job overview
The Pharmacovigilance Specialist will support Local Pharmacovigilance Organization on various activities related to the Global Safety Database to ensure that reporting rules are set in accordance with local regulations and any product vigilance agreements with third party business partners. Acts as a Subject Matter Expert (SME) for reporting rules and Global Safety System.
Principal responsibilities:
General
Support the LSOs on applicable operational tasks and coordinate communications to the LPV Organization. Work in close partnership with members of LPV across all regions to ensure a global consistent approach for Safety.
Safety and PV System Management
Act as SME within Local Pharmacovigilance Organization for Reporting Rules and any related issue.
Act as an SME to support the translation of a regulatory requirement to reporting rules.
Support to LSOs globally on request to create and or update reporting rules to reflect regulatory requirements and agreements.
Responsible for maintenance and update of the bi-annual revision of reporting rules to ensure that criteria are met as per regulatory requirements and agreements.
Work in cooperation with Global Safety Reporting Team to understand the logic of reporting rules and to detect areas of improvement.
Identify and investigate Reporting Rules and Submission issues and make recommendations for resolution.
Support on investigations due to Reporting Rule set up or any issues related to the Global Safety System that impact the LPV Organization
Support base business activities related to the Company Product Dictionary (CPD) and represent LPV in discussions related to CPD issues and enhancements.
Procedural Document
Develop, update, and implement global procedures for LPV.
Audit and Inspection readiness
Support in audits/inspections, including responding to queries and collaborating with the global teams, when needed.
Qualifications:
Education: Medical/ Health Sciences and/or proven equivalent experience in pharmacovigilance and safety issue management
Years of Related Experience: A minimum of 5 years' experience
Fluent communication skills in English, any additional language is a plus.
Computer literate with knowledge of relevant IT safety systems.
Strong ARGUS expertise, preferably with hands-on experience in the setup and maintenance of reporting rules.
Ability to effectively partner with and support LSOs and stakeholders globally.
Strong stakeholder management, problem-solving, and communication skills.
Skills:
Proven ability to organize workflow activities.
Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
Knowledge of global, regional, and local procedural documents as applicable.
Good verbal and written communication skills.
Ability to establish and maintain open relationships within the organization.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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