The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Pharmacovigilance Quality & Compliance Lead (GVP) for a remote opportunity.

Role Description

Specific tasks include:
• Provides expert guidance on Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) global regulatory expectations (FDA, EMA, ICH), and industry best practices to ensure compliance and operational excellence.
• Provides support to Phase IV study types (i.e. Non-Interventional Studies, Compassionate Use, Surveys, Managed Access Programs, Named Patient Programs, Patient Centered Outcomes Research, Registries).
• Provide oversight to UCB patient centric initiatives (including patient support programs, market research programs, digital initiatives, IIS, PASS, medical information, collaboration studies).
• Ensures PV outputs are compliant including individual case safety reports (ICSRs), development safety update report (DSURs), Risk Management Plan (RMPs), and Risk Evaluation and Mitigation Strategies (REMS), etc.
• PV Quality Management Support - The Pharmacovigilance Quality & Compliance Lead GVP develops and executes a comprehensive and efficient Quality Assurance strategy for the critical PV processes, aligning with UCB SOPs and regulatory requirements.
• The role monitors compliance with global regulatory requirements by ensuring the implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level.
• Support to REMS activities. Ensuring timely completion and compliance with REMS noncompliance plans. This includes conducting internal reconciliations with the REMS Coordinating Centers, performing quality checks, and maintaining records for FDA inspections in UCB validated platforms. Track and monitor the progress of REMS deviations.

Skills & Requirements

• Bachelor’s degree in Life Sciences, Master’s degree is a plus, with 8 – 10 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry.
• Proficiency in internal auditing, partner auditing, risk assessments, compliance monitoring, and inspection management activities preferred.
• Knowledge of GVP and GCP, and applicable regulatory framework.
• Ability to proactively identify, assess, and identify solutions to mitigate potential risks to the pharmacovigilance system.
• Ability to lead medium to high complexity projects.
• Excellent verbal and written communications skills in English.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

#LI-DNI