Intelliswift - An LTTS Company · 10 hours ago
Compliance Specialist (Global Regulatory Affairs and Drug Safety)
United States
Contract
Remote
Entry Level
1+ years expIntelliswift, an LTTS Company, is seeking a Compliance Specialist focused on Global Regulatory Affairs and Drug Safety. This role involves executing regulatory and pharmacovigilance compliance activities, supporting quality management systems, and overseeing procedural deviations and inspections.
Big DataBusiness IntelligenceCloud ManagementEnterprise SoftwareInformation Technology
Hiring Manager
Basant Sharma
Responsibilities
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
Qualification
Required
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)
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
Bachelor's degree in business or life sciences required
Preferred
Lean Sigma certification, or equivalent certification, preferred but not required
Company
Intelliswift - An LTTS Company
''Intelliswift, an LTTS Company, delivers world-class Digital Product Engineering, Data Management, Analytics & AI, and Digital Ent Solutions
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-11-11Acquired
Leadership Team
Pat Patel
Founder & Executive Chairman
Recent News
Business Standard India
2024-11-12
2024-04-08
Company data provided by crunchbase