Compliance Specialist (Global Regulatory Affairs and Drug Safety)
Must have:
• Pharmacovigilance (PV) / Drug Safety
• Regulatory Affairs (RA)
• CAPA (Corrective and Preventive Actions)
• Change Control & Deviations
• Inspection Readiness / Audits
• Aggregate Reports (PSUR, PADER, REMS)
• Quality Management System (QMS)
The GRADS Compliance Specialist contractor is responsible for executing Regulatory and PV compliance activities based on relevant regulations, procedures, and contractual requirements. Through the implementation of quality and compliance tracking tools/reports, oversight strategy, and relationship management, this role will support the development and management of continuous improvements across the Regulatory and Pharmacovigilance system, including the implementation, tracking, maintenance, and effectiveness checking of all Regulatory and PV quality system-related activities. The incumbent will support the organization and maintenance of Regulatory and PV compliance activities with metrics. Substantial focus will be placed on overseeing Regulatory and Pharmacovigilance procedural deviations, CAPA, change control management activities and inspection readiness.
Essential Functions
• Support investigations, development of corrective and preventative action (CAPA) and effective measures for Regulatory and PV related change controls, deviations, audits and inspections.
• Support GRADS Regulatory and/or Labeling sub-functions to enhance compliance activities with a focus on inspection readiness.
• Perform quality review of assigned aggregate reports (PSUR, PADER, REMS Assessment Report, etc).
• Support the management of Regulatory and Pharmacovigilance issues, deviations, CAPA development, and change control management.
• Collaborate with GRADS Compliance team members in executing global Regulatory and PV compliance activities.
• Identify and escalate critical quality issues to senior GRADS Compliance management.
• Support (as determined by line management) Regulatory and PV process improvements including authoring/updating controlled procedures as it relates to compliance activities.
• Assists with inspection related activities, (pre-, peri- and post-inspection).
• Remain current with global regulatory affairs, labelling and PV regulations and requirements, evaluate legislative changes affecting Regulatory, Labeling and PV, and develop strategies to support patient safety.
• Monitor the PV Compliance mailbox to ensure timely actioning of communications.
Required Knowledge, Skills, and Abilities
• Minimum 1 year business, pharmaceutical, or biotechnology industry experience
• Can apply base level quality control technical concepts and skills
• Developing written and verbal communications skills
• Ability to work in a fast-paced environment
• Individual contributor with oversight from line manager
• Ability to work across geographical boundaries
• Disciplined, detail oriented, and good time management skills
Required/Preferred Education and Licenses
• Bachelor’s degree in business or life sciences required
• Lean Sigma certification, or equivalent certification, preferred but not required
Apply Now
Apply Now
• Pharmacovigilance (PV) / Drug Safety
• Regulatory Affairs (RA)
• CAPA (Corrective and Preventive Actions)
• Change Control & Deviations
• Inspection Readiness / Audits
• Aggregate Reports (PSUR, PADER, REMS)
• Quality Management System (QMS)
The GRADS Compliance Specialist contractor is responsible for executing Regulatory and PV compliance activities based on relevant regulations, procedures, and contractual requirements. Through the implementation of quality and compliance tracking tools/reports, oversight strategy, and relationship management, this role will support the development and management of continuous improvements across the Regulatory and Pharmacovigilance system, including the implementation, tracking, maintenance, and effectiveness checking of all Regulatory and PV quality system-related activities. The incumbent will support the organization and maintenance of Regulatory and PV compliance activities with metrics. Substantial focus will be placed on overseeing Regulatory and Pharmacovigilance procedural deviations, CAPA, change control management activities and inspection readiness.
Essential Functions
• Support investigations, development of corrective and preventative action (CAPA) and effective measures for Regulatory and PV related change controls, deviations, audits and inspections.
• Support GRADS Regulatory and/or Labeling sub-functions to enhance compliance activities with a focus on inspection readiness.
• Perform quality review of assigned aggregate reports (PSUR, PADER, REMS Assessment Report, etc).
• Support the management of Regulatory and Pharmacovigilance issues, deviations, CAPA development, and change control management.
• Collaborate with GRADS Compliance team members in executing global Regulatory and PV compliance activities.
• Identify and escalate critical quality issues to senior GRADS Compliance management.
• Support (as determined by line management) Regulatory and PV process improvements including authoring/updating controlled procedures as it relates to compliance activities.
• Assists with inspection related activities, (pre-, peri- and post-inspection).
• Remain current with global regulatory affairs, labelling and PV regulations and requirements, evaluate legislative changes affecting Regulatory, Labeling and PV, and develop strategies to support patient safety.
• Monitor the PV Compliance mailbox to ensure timely actioning of communications.
Required Knowledge, Skills, and Abilities
• Minimum 1 year business, pharmaceutical, or biotechnology industry experience
• Can apply base level quality control technical concepts and skills
• Developing written and verbal communications skills
• Ability to work in a fast-paced environment
• Individual contributor with oversight from line manager
• Ability to work across geographical boundaries
• Disciplined, detail oriented, and good time management skills
Required/Preferred Education and Licenses
• Bachelor’s degree in business or life sciences required
• Lean Sigma certification, or equivalent certification, preferred but not required
Apply Now
Apply Now