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Career Openings


Head of Global Patient Safety (GPS)

ID: 1577
Department: Drug Safety
Location: Cambridge Headquarters
# of Openings: 1

Description

It’s an exciting time for our business. After two decades of growth and innovation, in 2018 we announced our intent to create two focused, independent companies: Ironwood and “R&D Co.”:  This new way of doing business will enhance our agility and innovation, and empower our employees to make a bigger impact on patients and on our industry than ever before.

 

R&D Co. will harness our pioneering work in cGMP pharmacology to advance its portfolio of differentiated sGC stimulators being evaluated for treatment of serious and orphan diseases. Following completion of the separation, the Head of Global Patient Safety position will be a part of R&D Co. The role will remain as described here.

We are seeking a talented, highly motivated and experienced pharmacovigilance leader to join our fast-paced, Cambridge, MA based company. The position will report to the Head of Global Regulatory, Patient Safety and Quality.

As Head of Global Patient Safety (i.e. drug safety and pharmacovigilance) (GPS) you will establish a global vision and influence the drug safety mindset in support of our company mission and long-term objectives in creation of a leading edge, innovative GPS team. You will lead the function responsible for global product safety assessment and risk management, continuously evaluating the benefit-risk profile of our potential therapies, in accordance with applicable regulatory requirements, guidelines, and laws. You will develop the global strategy, operating model and corporate governance of GPS, as well as provide quality standards for drugs from pre‐approval to on-market support, when applicable. 

 

As Head of GPS, you will drive the values that comprise our company culture, be the champion for our commitment and efforts to proactively identify emerging potential and/or urgent safety issues and ensure the management and appropriate communication of any identified safety risk.  You will also identify and be accountable for effective and seamless management of strategic GPS partner(s) who will complement the execution of our mission – assessing the risk/benefit of pharmaceutical products and ensuring that they are safe for use in patients. 

 

You will be accountable for:

  • Leading a highly effective safety organization, building collaborative working relationships across the enterprise

  • Defining and implementing methods for the collection, evaluation, management and communication (externally to authorities, health professionals and patients, as well as partners; internally to Senior Leadership Team, Clinical Research, Regulatory Affairs etc.) of safety data from all sources related to our products.

  • Partnering with and advising clinical development teams

  • Evaluating/monitoring/managing oversight of strategic PV partner, professional consultants, and /or contractors to ensure compliance with company policies and regulatory requirements on safety data reporting, collection, surveillance activities and documentation.

  • Ensuring applicable review and oversight of pharmacovigilance systems in all aspects

  • Designing, implementing and managing risk management and benefit risk evaluation

  • Leading or supervising the medical evaluation/review of safety data and ensuring the oversight of safety signal detection activities and review for the allocated portfolio of products in development and on the market (when applicable).

  • Directing the compilation, quality and interpretation of safety data for reporting purposes, including marketing applications to regulatory agencies, in collaboration with Clinical Research.

 

Minimum Basic Qualifications, skills, competencies and experience:

  • M.D. or equivalent (D.O., M.B.B.S, etc.).

  • Minimum of ten (10) years of experience in pharmaceutical / biotech experience in risk management and pharmacovigilance (safety signal detection, data mining techniques, pharmacovigilance databases, etc.)

  • Proven track record as a leader; preferably accountable for a leading edge, high quality global pharmacovigilance team

  • Demonstrated success in leading, managing and developing team members

  • Proven track record of successful management of product safety matters (product recall, regulatory inspections, etc.)

  • Demonstrated experience in the preparation of global risk management plans, aggregate reports and Benefit/ Risk assessments

  • Experience with strategic partners, CROs, or vendors, and effective relationship management.

  • Expertise in multiple therapeutic areas (preferably including CNS, serious and/or orphan disorders).


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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