Pharmacovigilance Operations

Job Summary (Primary function)
The Senior Drug Safety Associate will be responsible for 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 leading case management lifecycle from receipt through case completion. The role will also be responsible to liaise with relevant parties (intradepartmental, external service provider/vendor or business partners) for related case processing tasks as required.

Essential Functions of the Job (Key responsibilities)
• Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials.
• Completion of 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).
• Assist with literature review and article procurement as required.
• Perform retrospective quality review and document findings, and contribute to metric compilation
• Assist with business partner and other query management.
• Represent Pharmacovigilance on project teams.
• Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
• Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required.
• Train and mentor case processing staff.
• Assist with creating 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.
• Other responsibilities, as required.

Qualifications (Minimal acceptable level of education, work experience, and competency)
• Bachelor’s degree in a science or healthcare related discipline (nursing/pharmacy preferred), or equivalent.
• Minimum of 4 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
• Proficiency using safety database systems (Argus experience preferred).
• 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).
• Excellent ability to work effectively within a team environment.
• Advanced organizational, time management, and problem-solving skills.
• Ability to create and deliver presentations.
• Excellent verbal and written communication skills.
• Fluency in written and verbal English.

• Travel (domestic and global) 10%

• 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.