Pharmacovigilance Quality & Compliance Lead (GVP)

Please note: Required to use personal laptop for work, as the client will not be supplying any equipment.

Can be located Office (ATL or RTP priority); or Remote

Pharmacovigilance Quality & Compliance Lead (GVP)

We are looking for a Pharmacovigilance Quality & Compliance Lead (GVP) responsible for implementing and maintaining a balanced, proactive, global approach to pharmacovigilance (PV) compliance, to join us in our R&D and Pharmacovigilance Quality team.

About the role

The Pharmacovigilance Quality & Compliance Lead falls with the Impact Quality team within R&D and Pharmacovigilance Quality. This position is a global role responsible for ensuring pharmacovigilance (PV) activities are conducted in accordance with applicable global regulatory requirements, guidelines, polices, procedures and industry best practice. The ideal candidate for this position should possess GVP experience in the pharmaceutical industry and have work experience supporting pharmacovigilance quality assurance, along with a demonstrated track record of success in providing quality oversight to critical PV process such as case processing, aggregate reports, quality assurance systems, PV vendors, audits, Safety Data Exchange Agreements, etc. A candidate that also possesses GCP experience would be ideal or has a background in GVP auditing.

Who you ll work with

• The role will collaborate closely with COMPANY cross-functional teams supporting pharmacovigilance activities including the Global Pharmacovigilance organization, Affiliate Offices, Clinical Operations, Regulatory Affairs, Commercial teams, etc. Key responsibilities include overseeing the pharmacovigilance system and pharmacovigilance quality system and providing oversight to Phase IVs studies and post-marketing commitments.

What you ll do

The Pharmacovigilance Quality & Compliance Lead is responsible for providing Quality oversight to the COMPANY Pharmacovigilance System and the COMPANY Pharmacovigilance Quality Management System. 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 COMPANY 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 COMPANY 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 COMPANY validated platforms. Track and monitor the progress of REMS deviations.

Must have:
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.