Director, Post Market Surveillance

Director of Post Market Surveillance and Pharmacovigilance

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values dedicated, innovative, friendly, partners, and do the right thing our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions.

Responsibilities

The Director of Post Market Surveillance and Pharmacovigilance is responsible for overseeing post market surveillance, adverse events, recalls and pharmacovigilance for Cooper Surgical. Manages and oversees global initiatives as they impact the post-market surveillance activities for Cooper Surgical, and is responsible for the design, development, implementation, and maintenance of a compliant and effective post-market surveillance system. This may include communicating with the FDA for recalls, MDRs, periodic updates, pharmacovigilance, etc., and keeping senior leadership informed of post market feedback on Cooper Surgical products, services and processes. This role oversees the complaint handling process, is responsible for identifying and securing needed resources to ensure effectiveness, and successfully managing a team.

• Partner with Cooper Surgical senior management and site management to facilitate post-market surveillance across all locations.
• Partner with cross-functional team members to drive quality improvement activities and LEAN principles within the organization.
• Serve as the Cooper Surgical expert on post market surveillance activities, ensuring sites are supported through the decision-making activity, closure and termination of issues.
• Drive and establish robust and consistent evaluation methodology ensuring reporting of adverse events are consistently applied across all Cooper Surgical sites.
• Function as the subject matter expert on post market surveillance matters, including during external audits / inspections by regulatory authorities (i.e. Notified Bodies, FDA, etc.).
• Drive continuous improvement and LEAN activities with sites to improve efficiencies in post market activities.
• Function as champion for IT projects impacting post market function and / or systems.
• Implement periodic post market surveillance review meetings to provide senior management with information regarding complaints and feedback from post market space.
• Oversee the complaint management team ensuring that all feedback mechanisms are captured and addressed in a timely manner.
• Design, establish, implement, and maintain a resource plan that fully supports the needs of the business to capture post-market feedback.
• Ensure appropriate training is implemented company-wide for employees to understand the responsibilities for reporting customer complaints and the methods to communicate those complaints.
• Lead strategic planning, direction, and goal setting for the department or function.
• Instill a culture of continuous improvement by developing and implementing strategies that achieve measurable results.
• Manage a team of direct reports and provide guidance, coaching, evaluation and hiring of quality personnel as needed.
• Perform other duties as assigned.

Travel : This position may require 10-15% domestic and / or foreign travel.

Qualifications