Director Pharmacovigilance Compliance Training and Quality Job in Princeton, New Jersey 08540, New Jersey US

Job Description:

The Director Pharmacovigilance Compliance Training will assure compliance with worldwide regulatory requirements for all global safety and pharmacovigilance activities. He/she will monitor, investigate and assess global safety processes and procedures for consistency and compliance with global laws, regulatory requirements and Otsuka policies and procedures. He/she will lead global safety audit/inspection activities. He/she will develop quality check-points and metrics in addition to tracking and evaluating ICSR and aggregate safety reporting processes and metrics. evaluate global safety reporting processes and metrics, perform trending and identify areas for process improvement. Provides guidance, expertise, and broad support to the company (on a global level) in the interpretation of PV regulations, regulatory actions, and other regulatory developments. Develops and maintains SDEA and PV agreements with company affiliates, ensuring that company standards are upheld and international safety regulations are met. Develops and deliver internal training for all relevant personnel on global and local PV processes and regulatory compliance requirements.


Key Responsibilities:

PV Compliance

·        Leads and directs PV Compliance Training within Otsuka Pharmacovigilance.

·        Assures that Otsuka is in a continuous state of PV compliance with Otsuka policies and procedures, including country specific and other applicable standards, and worldwide regulations.

·        Develops processes and procedures that assure compliance with healthcare laws, regulations and guidance.

·        Monitors activities and performs audits to assure that business activities and transactions are consistent with company compliance guidance and that they conform to SOPs.

·        Generates, analyzes and reports PV compliance metrics to demonstrate key aspects of the PV compliance status.

·        Ensures drug safety reporting compliance for PSURs, DSURs, REMS, and RMPs.

·        Performs trending on root causes for late submissions (to business partners, third parties, affiliates, and regulatory authorities) to identify areas for process improvement

·        Provides input on revisions to controlled documents and training requirements, and identifies new documents and training

·        Identifies and elevates potential compliance risks and weaknesses. (e.g., enhancements to safety signal processes)

·        Maintains knowledge of pharmacovigilance regulations and company SOPs governing PV. Monitors global regulations for impact on PV functions and lead initiatives to ensure compliance when changes occur.

Global Safety Audit/Inspection

·        Oversee development, implementation and maintenance of PV quality management and compliance monitoring systems for inspection readiness.

·        Leads global safety audit/inspection activities, including preliminary preparation, internal host support and document/interviewee facilitation, development or recommendation of corrective actions related to audit/inspection findings, and follow up on commitments to ensure documentation is adequate and timelines met.

·        Leads interactions with regulators, external auditors and contractors, when appropriate.

·        Works with Quality Assurance and Quality Management to assure that the company meets its overall regulatory obligations.

PV Training

·        Assesses overall training needs for global safety and PV with input from senior management and staff and reports on these assessments with recommendations for training.

·        Manages internal as well as external training projects working with internal Subject Matter Experts (SMEs) and external consultants

·        Develops and maintains training curriculum consisting of courses, seminars, e-learning modules as requested, and/or suggested improvements in current course curriculum.

·        Promotes continuous education on PV regulations for self and other Otsuka staff

·        Ensures accurate reporting and quality control of the Learning Management System

·        May be assigned to lead or assist with special projects or process development. May perform any other duties as needed.


Requirement:

·        Excellent knowledge of ICH, US EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required - ICSRs and aggregate safety reports)

·        Requires strong knowledge of regulatory inspections with the ability to effectively handle all situations that may occur and determine appropriate strategies and courses of action

·        Solid understanding of what regulators consider to be critical

·        Solid understanding of scientific and medical concepts within the PV program

·        Excellent knowledge of regulatory compliance activities necessary for day-to-day operations of PV management

·        Experience in conducting PV audits in the pharmaceutical industry

·        Ability to process information from multiple sources and ensure that the right audits are selected

·        Strong project management, interpersonal, communication and presentation skills

·        Experience in managing contract service providers

·        Ability to accomplish objectives through influence in a matrix organization

·        Strong computer skills with Word, Excel, PowerPoint, and Outlook

·        Advanced understanding of PV and Risk Management requirements in US, EU and Japan.

·        Experience with PV, GPC, GMP inspections conducted by FDA, MHRA, etc.

·        Experience with ARGUS or other Pharmacovigilance database is a plus

·        Advanced degree in life sciences plus minimum of eight years PV Compliance or Risk Management experience global setting preferred years in a life sciences company


Travel:

·         Global travel up to 30%


Apply Online at:

https://2xrecruit.kenexa.com/kr/cc/jsp/public/EmailJobDetail.jsf?npi=592BD0535B5F57261EE563929442C841rand=C6C81E6AC526D87102C5282332F44A4C


Company Description:

Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) is involved in conducting all phases of clinical research and development of innovative healthcare products to address unmet medical needs. OPDC is well established in the scientific community as a globally focused organization that plays a leadership role in the research and development of Otsuka's ethical healthcare products. The Company is dedicated to the improvement of the quality of human life and health of its patients around the world with a strong commitment to research and development in the areas of cardiovascular, respiratory, renal and neuroscience systems, and to treat cancer and ophthalmic disorders.