Global Pharmacovigilance Operations Specialist

Home-Based in North America, East Coast strongly preferred

Why DSSS?

Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading CRO while operating within a sponsor environment and utilizing sponsor systems. Being part of DSS means being part of a passionate team dedicated to advancing medicine and reshaping healthcare. Your role will be both challenging and rewarding, making a real impact.

Experience the best of both worlds and become a core part of our dynamic team today!

Additional Benefits:

Great work/life balanceCollaborate on projects and innovations with industry leaders in the Pharma and CRO sectors Cohesive team environment fostering a collaborative approach to study workVariety of therapeutic areas, indications and, study phasesJob stability; long-term engagements, and development opportunitiesCareer advancement opportunities

Responsibilities:

Support multiple activities including, but not limited to, the safety document distribution management system, Safety Reporting Plan review, safety database configuration review, MedDRA upgrade, IST/IIRs, post-marketing programs, Market Access/Research programs, and all applicable reconciliations. Departmental support, including during Audits and Inspections.Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes. Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times. Assist with GPRM efforts for initiating new PhVOps projects requiring coordination and set-up of support systems and processes, as required. Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources), as required.Assist with reviewing procedures (e.g. SOPs, Working Instructions, Job Aids), forms, and templates in support of efficient Project Management.Support compliance with internal procedures, regulatory requirements, and business partner agreements to ensure inspection readiness at all times.Support and perform case processing activities as needed including but not limited to intake, triage, book-in, data entry, peer/quality review, follow-up, and submissionsMaintain files and systems as appropriate. Completion of additional tasks and projects as assigned by management.

Education and Experience:

Bachelor’s degree in a Science or Healthcare related discipline or equivalent amount of relevant experience in the Pharmaceutical, Life Sciences, or Contract Research Organization industryMinimum of 8 years Pharmacovigilance and Risk Management experience in clinical trials supporting global pharmacovigilance activities including but not limited to case processing, reconciliation, supporting technical tasks, system related functions, and more.Proficiency using safety database systems (Argus experience preferred).General 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.Ability to travel to office for monthly departmental meetings at assigned client offices as well as for ad hoc meetings and/or urgent matters as needed.

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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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $102,700.00 - $171,100.00. 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.