Pharmacy Investigational Product Specialist

1 week ago

San Diego, California, United States IQVIA Full time

Job Summary:

The Pharmacy Investigational Product Specialist (PIPS) will serve as a subject matter expert for drug preparation as it relates to the process and procedure of the IPPI (Investigational Product Preparation and Administration Instructions), in clinical research. The PIPS will play a lead role in the development of safe, efficient, and effective investigational product (IP) preparation in clinical trials. The PIPS will be the key internal and external interface to ensure overall IP preparation adherence. The PIPS will be co-author of the IPPI, and will be responsible for training slide development, training level assessment evaluation, and staff training. The PIPS will give input in ancillary supply selection and ancillary supply related questions, study feasibility, site assessment and mentoring for IPPI. He/she will contribute to continuous IPPI process improvement. The PIPS will mainly focus on PIPS tasks for trials with an IPPI.

Responsibilities:


• Services rendered will adhere to applicable Johnson & Johnson Standard Operational Procedures (SOP), Work Instructions (WI), Job Aids (JA), policies, local regulatory requirements, etc.


• PIPS will be part of the IPPI author team: PIPS will be responsible for the preparation sections of the different IPPIs (IV, Subcutaneous, IM, Oral, etc.) based on the provided information about the IP (presentation, dosage, stability, material compatibility, etc.), and their expertise to identify the risk factors related to IP preparation.


• PIPS will create the IP preparation training materials for the different IPPIs and evaluate the training level required for site staff.
• PIPS will train the team on the preparation of IP for all versions of the IPPI according to the J&J SOPs and WIs.


• PIPS will be accountable for the oversight of the site trainings on the IPPI based on the Training Level Assessment Form (TLAF).


• PIPS will remotely support the study teams with: Site trainings on IPPI, when required. Questions about IP preparation. Site findings related to the IPPI (according to SOPs, study guidelines and blinding requirements)


• PIPS will be involved in the oversight of findings related to the IPPI, including attendance of Protocol Deviation and Issue Escalation (PDIE) meetings when required. PIPS will provide input in the ancillary supply (AS) process (development of AS Questionnaire, selection of supplies, etc.). PIPS will also coordinate questions related to AS in close collaboration with the Ancillary Support Associate (ASA).


• PIPS will provide input in pre-trial activities and study feasibility, including the development of IPPI-related questions for the Site Interest and Protocol Information Questionnaire (sipIQ).


• PIPS will share their hospital pharmacy background/knowledge and expertise with the Drug Product Assessment Team (DPAT).


• PIPS will support IPPI related initiatives and working groups. They will actively participate in discussions about pharmacy practice.


• PIPS will build strong relationships with the different customers to understand the evolving pharmacy standard practices, and the current and future country and local regulations. They will integrate these trends into the current and future IPPIs.
• PIPS will perform all administrative requirements in a timely, accurate and compliant manner (e.g., time reporting, expense reports, documentation, filing of relevant communications, etc.).

Education and Experience Requirements:


• For US: Pharm D. degree with minimal 3-4 years of recent experience in a hospital or ambulatory clinic or a BS degree in Pharmacy with at least 4 years of recent experience in a hospital or ambulatory clinic is required.


• Experience in antibody treatment (Oncology (hematology and solid tumor) and / or Immunology Therapeutic Area)


• Experience in preparing different drugs depending on the way of administration, especially intravenous, subcutaneous, and intramuscular.


• Experience in the (virtual) clinical trial setting.


• Experience in working with Microsoft Suite, including: Word, Power Point, One Note, Teams and Excel.


• Strong written and oral communication, authoring and presentation skills.


• Must be proficient in speaking and writing in the country language and English.


• Organized mindset to be able to work on multiple studies in parallel for different TA.


• Proactive, innovative, and creative mindset with strong attention to details.


• Ability to work in a team environment and to collaborate with all levels of management across a matrix organization.


• Problem solving skills with ability to make decisions.


• Speaking up when required and working under pressure

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

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.

The potential base pay range for this role, when annualized, is $82, $137, 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.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q2 Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled


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