Pharmacovigilance Workstream Lead

2 weeks ago

Malvern, Arkansas, United States PharmaLex Full time
Job Description

PharmaLex is seeking an 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.

Main Responsibilities:
  • Ensure compliance with regulatory requirements and drive continuous improvement initiatives to enhance drug safety and minimize risks associated with pharmaceutical products.
  • Responsible for determining the pharmacovigilance activities scope and objectives, develop project plans and monitor progress.
  • Lead in the initial design and configuration of the global pharmacovigilance framework to accommodate a client's strategic needs.
  • Lead and manage pharmacovigilance activities within a specific workstream or therapeutic area, ensuring alignment with organizational objectives and regulatory standards.
  • Responsible for generating accurate and timely reporting of pharmacovigilance activities status to internal and external stakeholders.
  • Develop and execute strategic plans for pharmacovigilance activities, including signal detection, risk management, case processing, aggregate reporting, and safety surveillance, as well as operational plans for scaling to other geographic and therapeutic areas.
  • Provide guidance and mentorship to pharmacovigilance team members, fostering a culture of excellence and continuous improvement.
Key Performance Indicators:
  • Attainment of yearly goals according to client agreement.
  • Ensures effective and transparent communication and working relationships with client and workstream team members.
  • Evaluates and assesses the results of the workstream with review of available metrics and KPIs, resource updates, and budgets.
Regulatory Compliance:
  • Stay abreast of evolving regulatory requirements related to pharmacovigilance and ensure adherence to applicable regulations and guidelines (e.g., FDA, EMA, ICH).
  • Collaborate with regulatory affairs teams to coordinate and submit pharmacovigilance-related documentation for regulatory authorities, including periodic safety reports and risk management plans.
  • Manage a state of always ready for inspection while participating in ongoing PV inspections and audits.
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.
  • Collaborate with external partners, including contract research organizations (CROs) and regulatory agencies, to facilitate pharmacovigilance-related activities and ensure timely execution of deliverables.
  • Integrate internal experts, the client and external partners into the pharmacovigilance activities.
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 on behalf of the client.
  • Support the implementation of corrective and preventive actions (CAPAs) as necessary to address findings from audits, inspections, or internal reviews.

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