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Pharmacovigilance Workstream Lead

2 months ago

Malvern, Arkansas, United States PharmaLex Full time
Job Summary

PharmaLex is seeking a highly skilled and experienced Pharmacovigilance Workstream Lead to join our team. As a key member of our Pharmacovigilance department, you will be responsible for overseeing the pharmacovigilance activities of a designated workstream or therapeutic area team.

Key Responsibilities
  • Workstream Leadership: Responsible and accountable for assigned workstream to ensure that overall workstream is within expected costs, resources, timelines and budget and meets expected quality standards according to defined client agreements and expectations.
  • Pharmacovigilance Activities: Responsible for determining the pharmacovigilance activities scope and objectives, develop project plans and monitor progress.
  • Regulatory Compliance: Stay abreast of evolving regulatory requirements related to pharmacovigilance and ensure adherence to applicable regulations and guidelines (e.g., FDA, EMA, ICH).
  • Cross-Functional Collaboration: Work closely with other departments such as clinical development, medical affairs, and quality assurance to integrate pharmacovigilance activities into product development and lifecycle management processes.
  • Quality Assurance and Process Improvement: Support audits, inspections and assessments of pharmacovigilance processes and systems to ensure compliance with quality standards and identify opportunities for improvement.
Requirements
  • Proven experience in pharmacovigilance and leadership roles.
  • Strong knowledge of regulatory requirements and guidelines.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
What We Offer
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.