Job Summary

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 Incyte 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

• Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte 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 Incyte 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

• 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 Incyte offices as well as for ad hoc meetings and/or urgent matters (notice period: 24 hours or less) as needed.

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

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $62,800.00 - $157,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.