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Career Openings


Sr. Manager – Drug Safety and Pharmacovigilance Vendor Management

ID: 1442
Department: Drug Safety
Location: Cambridge Headquarters
# of Openings: 1

Description

Position Description:

The Senior Manager is responsible for acting as the DSPV Compliance and Alliance (C&A) Liaison.  Through the implementation of compliance and alliance management tracking tools, oversight strategy and relationship management, this role will ensure alignment with all applicable regulations, internal procedures and contractual obligations through collaboration with impacted functions and roles. Proactive and insightful analytical and management skills are required, including an understanding of how to interpret regulatory requirement, business requirements, alliance partnerships strategies and environment. This role will be critical to manage and improve existing Pharmacovigilance Agreements (PVAs). Ability to adjust processes as needed while maintaining full compliance to internal and external standards and translate these into efficient processes will be key.  This role will also contribute to the development and implementation of a comprehensive training program for internal and external stakeholders, of a comprehensive quality system meeting or exceeding business best practices and PV regulations, and the implementation of compliance and process improvement metrics.    Effective communication, project management skills and the ability to develop efficient relationship and partnership with internal and external stakeholders will be critical success factors. The incumbent is accountable for maintaining current knowledge of key regulatory changes, scientific best practices, contractual changes, and planned company alliances to ensure future changes are anticipated and incorporated into existing procedures and practices.  

 

Responsibilities:

  • Serve as a key point of contact for other company's functions, vendors and partners interfacing with DSPV, under supervision and guidance of the Head of DSPV C&A

  • Assist the DSPV C&A leadership in the preparation, negotiation, finalization and monitoring of Pharmacovigilance Agreements (PVAs), according to an upon agreed strategy

  • Develop tools to track the commitments, roles and responsibilities across the existing PVAs

  • Develop PVA templates and dashboards to summarize existing PVAs obligations

  • Maintain project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks

  • Contributes to the DSPV C&A efforts to generate tracking tools to monitor compliance to training based on regulatory requirements, applicable internal and external procedures, contractual requirements and scientific best practices

  • Track, manage, and report qualitative and quantitative compliance for all DSPV applicable activities and alliance information

  • Develop and implement a comprehensive training program, including training matrix, training material and implementation strategy, and efficacy measurement

  • Assists the DSPV C&A leaders in the preparation and execution of the DSPV C&A compliance and process improvement activities, including the implementation of identified actions, CAPAs and Deviations writing and implementation, and self-identified process improvement measures implementation

  • Support the DSPV group during internal or external audits, and during PV regulatory inspections

  • Utilize interpersonal communication and change management skills clearly, unambiguously, and concisely

  • Research potential new or alternative resources and procedural solutions to support process efficiencies and regulatory compliance

  • Develop an efficient and collaborative partnership with the assigned Ironwood QA representatives

  • Provide regular communication, training and guidance to compliance and alliance internal and external stakeholders

  • Maintain current knowledge of key regulatory changes, scientific best practices, contractual changes, and planned company alliances to ensure future changes are anticipated and incorporated into existing procedures and practices

  • Collaborate and communicate effectively with internal and external resources and subject matter experts

 

Job Requirements:

  • BA/BS degree required.  Higher degree preferred

  • 7+ years’ experience within the biotechnology/pharmaceutical industry required

  • Understanding of and experience with ICH and other international regulations/guidelines for pharmacovigilance (PV), quality, compliance, and alliance management  systems

  • Experience with PV vendor and business partner management including tracking, compliance oversight and contract/agreement management

  • Minimum 3 years of pharmacovigilance experience (operations, quality and training, alliance management)

  • Solid communication skills (verbal and written), interpersonal skills and professionalism

  • Strong analytical, critical thinking, judgment, negotiating and problem solving skills

  • Ability to work independently, as well as within a cross-functional team environment

  • Ability to work in a dynamic environment and manage competing priorities

 

Competencies:

  • Issue Resolution – Proficient at identifying root cause and reaching rapid resolution

  • Listening and Effective Communication – Active listening to understand the needs of business users and provide regular, clear, concise written and verbal communication to internal and external stakeholders

  • Resource Management –   Able to effectively determine/manage the appropriate resource (internal or external) to achieve the most cost-effective result

  • Innovation Management – Good at bringing creative ideas of others to market; has good judgment about which creative ideas and suggestions will work; can facilitate effective brainstorming; can project how potential ideas may play out in the marketplace

  • Problem Solving – Uses logic and methods to trouble shoot and propose effective solutions

  • Perspective and Collaboration – Has a broad view of issues/challenges; thinks globally; considers near-term and future issue impacts; weighs risks and potential gains; works collaboratively

  • Accountability – Demonstrates ownership of roles and responsibilities


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





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