Summary:
The Senior Director Pharmacovigilance (PV) Operations will be accountable for the overall PV operations, which includes all aspects of adverse event collection, processing and reporting from all sources, vendor management, and associated PV quality management, for entire portfolio in clinical development and post approval. The Senior Director PV operations leads the PV operations team and plays a critical leadership role in internal and external collaboration to ensure PV operational excellence and regulatory compliance.

Responsibilities:

• Develops and implements the strategy for PV system, processes, and vendor deployment.
• Responsible for all PV operational aspects for entire portfolio in clinical development and post approval.
• Oversees the system for ICSR collection, processing, reconciliation, and reporting, including associated quality and training activities to ensure regulatory timelines and global standards are met.
• Facilitates and ensures communication with internal functions and external vendors and license partners involved with receiving, investigating, or reporting AEs.
• Provides oversight on PV vendors performing safety services.
• Supports the development and maintenance of PV agreement with license partners and/or other parties.
• Supports PV procedure development and maintenance that address the processing, analysis and reporting of safety information to ensure proactive surveillance of compounds across life cycle.
• Supports PV audit, inspection, and CAPA activities as required.
• Supports signal detection, aggregate report preparation and safety labeling updates.
• Supports the preparation and review of the safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/MAA, and other regulatory submissions.
• Supports business development activities including due diligence when required.
• Ensures awareness and training of appropriate Company personnel and external groups of PV principles, policies, and SOP.
• Provides PV guidance and support for interdepartmental and/or corporate initiatives.
• Leads and develops PV operations team.
• Participates in the development and management of departmental budget.

Requirements:

• Health care degree (RN, Pharm D) or PhD in biomedical or pharmaceutical sciences and extensive drug safety experience highly desirable.
• Minimum 15 years of PV operations experience within the biotechnology or pharmaceutical industry is required, including 5 years in management position with direct reports on the sponsor side overseeing business process outsourcing vendors and relationships. Experience with marketed and development stage oncology products is preferred.
• Expert knowledge of global PV requirements, e.g., US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
• Experience and extensive working knowledge of MedDRA and proprietary safety databases.
• Experience and extensive working knowledge of PV processes for individual case handling, signal detection and evaluation, aggregate data assembly, review, and report, as well as clinical study safety management.
• Extensive experience with audit and inspection.
• Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels.
• Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization.
• Proficient with Microsoft Office
• Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to details

Posted On: Tuesday, January 7, 2025