Compliance Specialist (Regulatory & Pharmacovigilance)

True Title: GRADS (Global Regulatory Affairs/Drug Safety) Compliance Specialist Contract Length: 1 YearFinal Rate TBD (Estimating $65PH)

Global Regulatory Affairs/Drug Safety Compliance Specialist

MUST HAVE'sBachelors Degree Pharma OR Biotech industry experience with the following:3-5 years of Regulatory & Pharmacovigilance Compliance experience (MUST HAVE BOTH)Experience supporting Regulatory and PV compliance activities (metrics, procedural deviations, CAPA, change control management activities, inspection readiness, etc.)Compliance related to: Aggregate Reporting, Regulatory Submissions and LabelingAbility to work independantly & hit the ground running

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/ResponsibilitiesSupport 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 AbilitiesMinimum 2 years business, pharmaceutical, or biotechnology industry experienceKnowledge of Good Pharmacovigilance Practices (GVP) is requiredKnowledge of Regulatory Affairs and/or Labelling regulations are requiredCan apply base level quality control technical concepts and skillsExcellent written and verbal communications skillsAbility to work in a fast-paced environmentIndividual contributor with oversight from line managerAbility to work in a team environment and support stakeholderAbility to work across geographical boundariesDisciplined, detail oriented, and good time management skillsAbility to influence or gain acceptance from others in sensitive situationsSelf-directed and ability to take action as needed with limited oversight

Required/Preferred Education and LicensesBachelor’s degree in business or life sciences requiredLean Sigma certification, or equivalent certification, preferred but not required