Mar 14, 2019

Associate Director, Pharmacovigilance Operations

  • Audentes Therapeutics
  • San Francisco, CA, USA
Full time Pharmaceutical Research Medical Affairs

Job Description

The Role

Reporting to the Vice President, Development Operations the Associate Director is responsible for the oversight and management of Pharmacovigilance activities, including oversight of aggregate reporting, overseeing signal management activities, oversight of management of responses to ad hoc regulatory responses, oversight of literature review/management for safety findings, and oversight of clinical trial safety activities. The Associate Director monitors resourcing and manages or reassigns tasks/projects across assigned programs and staff, as workload requires. The Associate Director is responsible for leading initiatives for process improvement, and collaborating across preclinical and clinical, and cross-functional groups to develop, implement and maintain processes that are compliant with global Pharmacovigilance regulations, improve efficiency and lead to consistent work processes across assigned product groups taking into account cross-program practices.

The specific responsibilities of this position include:

  • Overseeing aggregate reporting, clinical trial activities, signal management, literature review, and ad hoc regulatory responses.
  • Identifies process / procedural non-compliance, gaps or inefficiencies. Leads initiatives for process improvement and inspection readiness; implements and maintains processes.
  • Monitors and manages resourcing for assigned products to ensure compliant, high-quality, timely deliverables.
  • Serves as subject matter expert on relevant safety requirements, company policies / procedures related to Pharmacovigilance activities, as well as product and program knowledge.
  • Oversight of day to day safety monitoring activities, vendors, and safety operations of clinical trials.
  • Provide Pharmacovigilance subject matter expertise on Program Teams and other cross-functional platforms throughout the company.
  • Review and provide Pharmacovigilance input for development of protocols, IBs, CSRs and other relevant study documents.
  • Participate in writing of aggregate safety reports, e.g., DSURs, PSURs.
  • Facilitate cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda.
  • Provide subject matter expertise and input for regulatory submissions, e.g., NDA, MAA and regulatory responses, collaborating with cross-functional areas as appropriate.

Required Education, Skills and Experience

  • BS  in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with  6+ years' of biotech or pharmaceutical industry experience, including 5+ years' working directly in Pharmacovigilance.
  • Expert knowledge of global safety regulations, MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases.
  • Extensive Pharmacovigilance operations background including case processing, SAE reconciliation, CRF design, protocol review, and ICF maintenance.
  • Proven experience reviewing cumulative safety data with ability to interpret, synthesize, communicate, and present complex clinical /pharmaceutical information.
  • Strong experience in the preparation and authoring of pre- and post- aggregate safety reports.
  • Thorough understanding of the drug development process and context applicable to safety surveillance activities.
  • Proven ability to execute and follow-through to completion.
  • Demonstrated ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
  • Strong vendor management skills to ensure collaboration, oversight, and efficiency with vendors
  • Independently motivated, detail oriented and good problem solving ability.
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
  • Excellent communication skills and ability to influence across multiple functions.

Preferred Education, Skills and Experience

  • Previous experience in rare disease therapeutic area. 

Job Details

Reference # 2019B-079
Posted on 25 Jan 2019
Closes on  
Location(s) San Francisco
Department Clinical Development
Career level Management
Hours/Status Full-time

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