Associate Director/Director

6 days ago

Malvern, Arkansas, United States PharmaLex Full time
Job Title: Associate Director/Director

PharmaLex is seeking an experienced Associate Director/Director to lead our Pharmacovigilance Workstream. As a key member of our team, you will be responsible for overseeing the pharmacovigilance activities of a designated workstream or therapeutic area team.

Key Responsibilities:
  • Ensure compliance with regulatory requirements and drive continuous improvement initiatives.
  • Foster cross-functional collaboration 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.
  • Provide guidance and mentorship to pharmacovigilance team members, fostering a culture of excellence and continuous improvement.
Requirements:
  • Attainment of yearly goals according to client agreement.
  • 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.

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.

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.

The employee agrees to take over other reasonable tasks that are correspondent with his abilities if asked by the general management.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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