Associate Director, Pharmacovigilance job in New York, USA

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Job type: Permanent

Discipline: Pharmacovigilance

Location: United States

Associate Director, Pharmacovigilance - Permanent - New York, NY

��ٸ��Ƶר�� is seeking an Associate Director, Pharmacovigilance to oversee and manage pharmacovigilance operations for clinical development programs in the neurology and biotechnology space.

Primary Responsibilities:

The successful candidate will have the opportunity to contribute to the growth of a global patient safety function while ensuring compliance with regulatory standards and operational excellence.

Skills & Requirements:

Bachelor's degree in a science-related field or equivalent healthcare qualification (e.g., BSN, MSN, RN, RPh, PharmD, PhD).
Extensive experience in pharmacovigilance/drug safety within the pharmaceutical industry, including investigational drug safety.
Strong understanding of neurology therapeutic areas is advantageous.
Proven ability to supervise individuals or teams in a matrix environment.
Expertise in regulatory compliance, safety data management, and vendor oversight.
Excellent organizational, communication, and problem-solving skills.

The Associate Director, Pharmacovigilance's responsibilities will be:

Oversee outsourced pharmacovigilance (PV) activities, including maintaining direct communication with vendors to identify and mitigate operational risks.
Monitor compliance through key performance indicators (KPIs) and quality indicators (KQIs), ensuring high-quality PV deliverables from CROs, vendors, and partners.
Manage case processing activities, SUSAR submissions, and the development of safety management plans (SMPs).
Support the preparation and review of safety sections in clinical documents, such as Development Safety Update Reports (DSURs) and Investigator Brochures.
Ensure regulatory compliance for case submissions, aggregate study reports, and other safety deliverables.
Collaborate on the implementation of PV technologies and maintain oversight of safety databases.
Address and resolve SAE/AESI queries, track escalations, and ensure timely query resolution.
Partner with the Quality team to report deviations, conduct CAPA investigations, and monitor non-compliance issues.
Draft and maintain departmental SOPs and work instructions related to PV operations.
Represent PV Operations on global program and study teams, providing guidance on safety data collection and compliance.
Support inspection and audit requests related to PV operations.
Stay updated on global PV regulations and industry best practices to enhance operational efficiency.

Compensation:

$200 000.00 - $250 000.00 Per Annum

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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