• Director Pharmacovigilance

    Job Locations US-NJ-Jersey City
    Job ID
    2018-1309
    # of Openings
    1
    Type
    Full Time Regular
    Category
    Product Development
    FLSA Status
    Exempt
    Work Shift
    N/A
  • Overview

    The Director, Pharmacovigilance (PV) is responsible for establishing, leading and coordinating all processes supporting drug safety for Noven’s commercial products and clinical trial programs. The Director of PV is responsible for management and oversight of all PV operations and compliance with internal SOPs and applicable global regulations and guidelines.

    Responsibilities

    • Provides leadership and line management to the PV department and oversight of internal PV staff and PV operations and activities of vendors/CROs across multiple locations, aligning with other parts of the organization, where necessary.
    • Coordinates and monitors the implementation of PV agreements and safety management plans with all license partners and vendors and continuously monitor performance and compliance.
    • Maintains oversight of PV SOPs, drug safety plans and coding conventions. Assessing potential gaps, and identifying high-risk areas. Makes recommendations for improvements and leads close collaborations with subject matter experts on content development and alignment.
    • Implements PV training programs for internal and external needs.
    • Supports development of and implementation of appropriate drug safety and quality programs and processes compliant with the US combination product safety reporting rule.
    • Actively participates in regulatory inspections and internal audits and in collaboration with QA and Regulatory Affairs ensures appropriate and timely responses to findings
    • Coordinates PV corrective action/preventive action (CAPA) plans, ensure appropriate root-cause analysis and documentation. Recommends process development or improvement as needed
    • Enhances PV metrics capabilities. Evaluates trend analyses as related to the ongoing assessment of PV quality, consistency, reporting compliance and operational effectiveness
    • Supports ongoing safety surveillance of company products, contributes to regulatory submissions, aggregate reports and provides quality assurance for reports prior to submission to assure consistency, accuracy and compliance.
    • Monitors and supports the availability and use of the current reference safety documents for ICSR processing, aggregate safety reporting and safety data analyses
    • Keeps up to date with current regulatory requirements and trends regarding PV. Leads, coordinates or performs impact analysis.
    • Liaises with and is a trusted effective team member with other functional areas such as Regulatory Affairs, Clinical Development, Quality Assurance, Medical Affairs, Manufacturing, Legal and parent company Hisamitsu and other affiliates.
    • Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions.
    • Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with project priorities.
    • Actively installs the Noven values in the Safety Team and their activities.

    Qualifications

    Competencies:

    • Excellent communication and interpersonal skills.
    • Quality, processes and compliance oriented.
    • Strong scientific writing skills with ability to interpret, synthesize and present complex data and information.
    • Excellent organizational and project management skills with demonstrated ability to multi-task and adapt to changing priorities.
    • Takes initiative and autonomous action
    • Effective leadership and performance management of team members.
    • Proven ability to work cross culturally and collaboratively in an international environment and with cross-functional teams

    Education / Experience:

    • Bachelor’s degree in pharmacy, nursing, life sciences or equivalent. Masters or PharmD or other advanced degree is preferred.
    • Minimum of 8 years of pharmaceutical/biotech industry experience including a minimum of 5 years directly working in pharmacovigilance/drug safety operations or PV quality management.
    • Thorough knowledge and understanding of global regulations for safety and pharmacovigilance for both clinical trials and commercial products including FDA and ICH guidelines.
    • Knowledge of and experience with MedDRA coding.
    • Knowledge of and experience with drug safety databases (preferably Argus).
    • Experience with regulatory inspections and pharmacovigilance system audits.
    • Knowledge of the US safety reporting requirements for Combination Products
    • Proven experience leading a team of individuals located across a number of sites and leading them to optimize their performance and contribution.
    • Knowledge of transdermal products and/or relevant therapeutic areas (Women’s Health, Psychiatry, pain) is desirable.

    Work Environment:

    Office setting, ergonomic cubicle workspace, laptop and desktop provided. Some domestic and international travel may be required on an infrequent basis. 

     

    Physical Demands:

    • Ability to utilize computer in seated or standing position    

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