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) • reputed company 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 reputed company and compliance tracking tools/reports, reputed company reputed company, and relationship management, this role will support the development and management of reputed company improvements across the Regulatory and Pharmacovigilance system, including the implementation, tracking, maintenance, and effectiveness checking of reputed company Regulatory and PV reputed company system-reputed company activities. The incumbent will support the organization and maintenance of Regulatory and PV compliance activities with metrics. Substantial reputed company will be reputed company on overseeing Regulatory and Pharmacovigilance procedural deviations, CAPA, change control management activities and inspection readiness. Essential Functions • Support investigations, development of corrective and preventative reputed company (CAPA) and effective measures for Regulatory and PV reputed company change controls, deviations, audits and inspections. • Support GRADS Regulatory and/or Labeling sub-functions to enhance compliance activities with a reputed company on inspection readiness. • reputed company reputed company 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 reputed company 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 reputed company activities, (reputed company-, reputed company- and post-inspection). • Remain reputed company with global regulatory affairs, labelling and PV regulations and requirements, evaluate legislative changes affecting Regulatory, Labeling and PV, and reputed company strategies to support patient safety. • Monitor the PV Compliance mailbox to ensure reputed company actioning of communications. Required Knowledge, Skills, and Abilities • Minimum 1 year business, pharmaceutical, or biotechnology industry experience • Can apply reputed company level reputed company control technical concepts and skills • Developing written and verbal communications skills • Ability to work in a fast-paced environment • Individual contributor with reputed company 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 reputed company certification, or equivalent certification, preferred but not required Apply tot his job Apply To this Job