Offer summary

Qualifications:

Minimum 4-7 years of pharmacovigilance or related clinical experience., Expertise in safety database systems, especially Argus., Advanced knowledge of global pharmacovigilance regulations and guidelines., Excellent communication, leadership, and organizational skills..

Key responsibilities:

Lead processing and oversight of adverse event reports and safety data.

Manage case lifecycle from receipt to completion and lead pharmacovigilance teams.

Liaise with internal and external stakeholders on pharmacovigilance issues.

Support case management activities, data processing, and quality reviews.

Job description

Qualifications
•Minimum of 4-7 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience
•Safety database system expert (Argus required)
•Advanced knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices
•Excellent computer skills (i.e
•Microsoft Word, Excel, Outlook, and Power Point)
•Ability to lead teams
•Advanced organizational, time management, and problem-solving skills
•Proficiency with creating and delivering presentations
•Excellent verbal and written communication skills
•Fluency in written and verbal English

Responsibilities
•This position will be responsible for leading processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials
•The position will be responsible for oversight and leading case management lifecycle from receipt through case completion
•The position will also be responsible to lead Pharmacovigilance teams and groups and liaise with relevant parties (intradepartmental, external service provider/vendor or business partners) for related Pharmacovigilance issues as required
•Support DSA teams within the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions
•Perform case processing (including case deactivations) and data gathering tasks within Argus Safety Database and other systems (i.e
•EDC systems)
•Lead literature review and article procurement as required
•Lead project start-up activities including safety reporting plan review, safety database configuration/updates, regulatory/submission impact analysis, training and tracking as applicable
•Lead and perform retrospective quality review and document findings, and contribute to metric compilation
•Lead business partner and other query management
•Represent Pharmacovigilance on project teams
•Provide in-depth technical expertise on Pharmacovigilance processes and systems
•Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes
•Lead Pharmacovigilance data reconciliation including databases and listings (post marketing and clinical trial sources) as required
•Train and mentor case processing staff
•Actively identify process improvement and efficiency needs and escalate as needed
•Create procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes
•Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times
•Maintain files and systems as appropriate
•Assist with resource management processes, including line management of assigned junior operational staff
•Completion of additional tasks and projects as assigned by management
•Ability to travel to office for monthly departmental meetings at assigned offices as well as for ad hoc meetings and/or urgent matters (notice period: 24 hours or less) as needed

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Required profile