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Associate Director Global Patient Safety Operations

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Associate Director Global Patient Safety Operations

  • Location:

    Boston, United States

  • Sector:

    Life Sciences

  • Contact:

    Sam O'Donoghue

  • Job ref:

    497

  • Published:

    about 2 months ago

  • Expiry date:

    2020-12-31

Position Summary: As a key member of Global Patient Safety Operations, the Associate Director, is responsible for operational management and oversight of case processing activities, vendor management and supporting functions such as alliance management, quality & compliance, and safety systems.

The incumbent will join the Global Patient Safety Operations department reporting directly to the Director of Global Patient Safety.

Responsibilities:

Provide oversight of the pharmacovigilance (PV) operational and case management activities for safety reporting including the collection, processing, and reporting/submission of safety information for all Ironwood products (investigational and commercial) including the review and monitoring of compliance through various monitoring reports and other oversight activities

Provide Leadership and direction for all safety/PV operations related activities

Lead PV vendor management oversight activities including day-to-day oversight and guidance, review, and evaluation of the vendor performance and quality

Generate performance and compliance metrics for the PV vendor and monitor for trends or possible improvements

Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs) and PV agreements with partners

Lead and provide safety operations support on assigned studies

Support SAE reconciliation activities on assigned clinical studies and commercial products

Collaborate with study team members to develop documents related to safety case processing and reporting such as Safety Management Plan, Safety Reporting Forms and completion guidelines, reconciliation plan, data handling conventions

Collaborate with internal teams and vendors to prepare for Regulatory Authority inspections and internal/external audits as subject matter expert for PV operations

Contribute to safety requests from Regulatory Authorities and internal requests

Participate in the development and maintenance of PV Operation policies, procedures, and guidance documents to ensure compliance with all applicable regulatory requirements and guidelines, GVP and industry best practices

Review new or updated PV regulations for modifications to internal Ironwood procedures or changes to agreements with vendors or partners

Participate in cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation, and agenda

Collaborate with Clinical, Medical Affairs, and Commercial to develop processes, forms, and/or training to support Investigator Initiated Studies or other activities as assigned

Review and provide PV input for development of protocols, IBs, CSRs and other relevant study documents

Other responsibilities as assigned

Minimum Basic Qualifications:

Bachelor's degree in science with 10 years' relevant experience of which 5 years are at a US based pharmaceutical or biotech company within PV. Global pharmaceutical drug safety equivalent experience in combination with an advanced degree with less experience may be considered. In that case, a health professional degree (e.g., PharmD, BSN, RN, MPH) is preferred.

Knowledge of global safety regulations, expert knowledge of FDA, GVP, EU safety regulations, ICH Guidelines, and other applicable regulatory guidance documents

Safety reporting applications including knowledge of Argus Safety, clinical trial operations/electronic data capture and exchanges/reconciliations with the PV Database

Knowledge of MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases

Experience reviewing cumulative safety data with ability to interpret, synthesize, communicate, and present complex clinical/pharmaceutical information

Demonstrated project leadership, follow-up, critical, tactical and innovative thinking, problem solving and analytical skills and process development and process improvement experience

Excellent written and oral communication skills

Team player, open minded, creative thinker

Capable of working effectively under pressure in a multi-cultural environment, at any level of the organization, with a variety of stakeholders

Knowledge of project and change management tools and techniques; proficient in MS Word, excel, PowerPoint and SharePoint tools

Competencies:

Ability to perform the assigned safety activities in full compliance with applicable regulations and internal procedures

Ability to execute and follow-through to completion

Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

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.

Passion to learn new tools and technologies

Ability to focus on delivering excellent results and improving the performance of oneself and of Ironwood by taking initiative to try new approaches, while still following the rules (e.g., company, government and ethical), excel at an objective measure or goal, or do something that has never been done before

Ability to work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers or proactively seeking input from others to solve problems