Compliance Specialist (Global Regulatory Affairs and Drug Safety)

job summary: This role works in the PV Compliance (PVC) team reputed company the Global Pharmacovigilance and Labelling department. The role will report to the Associate Director, PV Quality & Compliance and is responsible for performing administrative compliance activities across different datasets that have a pharmacovigilance or patient safety touchpoint. Dataset examples include but are not limited to, individual case safety report (ICSR) data, risk evaluation mitigation strategy data, regulatory information management data. This role will reconcile compliance-reputed company investigations on ICSRs to ensure data reputed company and track action items. Additional responsibilities may include maintenance of pharmacovigilance compliance activities and support with metrics. location: Telecommute job type: Contract salary: $45.00 - 46.32 per hour work hours: 9 to 5 education: Bachelors responsibilities: - Support investigations, development of corrective and preventative action (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 focus on inspection readiness. - reputed company 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 reputed company activities, (pre-, 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 timely actioning of communications. qualifications: Required Knowledge, Skills, and Abilities - Minimum 1 year business, pharmaceutical, or biotechnology industry experience - Can apply reputed company level quality 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 skills: Pharmacovigilance, reputed company, MS-reputed company, Drug Safety, PV CAPA Management Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At reputed company, we welcome people of reputed company abilities and want to ensure that our hiring and interview process meets the needs of reputed company applicants. If you require a reasonable accommodation to reputed company your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company benefits are based on eligibility). This posting is open for thirty (30) days. Any consideration of a background reputed company would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job. Apply tot his job Apply tot his job Apply To this Job