Director, Global Safety and Pharmacovigilance Operations, Process, Quality, and Compliance

Prothena's success is driven by our people. We are dedicated to attracting individuals who share our vision to improve human health by putting patients first.

But it's not just about what we do at Prothena, it's how we do it. That's why we hire creative and courageous individuals who support one another and are not afraid to try new ideas. Our culture reflects our values which are brought to life every day by the following characteristics:

SELFLESS - Patients come first and we're in this together. Our environment is collaborative and we measure success through our collective accomplishments.

COURAGEOUS - Transformational innovation leads to novel treatments. "Tried-and-true" won't produce breakthroughs for patients – a pioneering spirit, willingness to accept certain risks and to try new approaches. Each Prothenian and functional team is expected to bring their heart, experience and trust on our journey.

IMAGINATIVE - We value and encourage a creative approach across all aspects of our work. We challenge ourselves and each other to think beyond what is known and approach our work through a lens of continuous improvement.

JOYFUL - Humor and heart allow us to tackle the seriousness of our work. Excellence and fun are not at odds – we love what we do and enjoy the journey.

Position Overview

The Director of Global Safety and Pharmacovigilance (GSPV) Operations, Process, Quality, and Compliance is responsible for the establishment, maintenance and oversight of appropriate procedures, metrics, and systems to assure compliance to global regulatory requirements for the collection, processing, and reporting of safety information throughout the product life cycle, (pre- through post-marketing). The incumbent serves as a strategic partner in managing GSPV quality and will provide support and collaboration internally and externally to ensure all systems, processes and outcomes comply with applicable global regulations and guidances, and industry and Prothena standards. This role will be deployed across the key areas of process and performance within the GSPV Operations remit: safety report case management, quality & compliance, safety agreements, and vendor management.

Responsibilities

• Develop GSPV strategy and infrastructure for GSPV processes, quality, and compliance; lead departmental process improvement
• Develop, implement, maintain, and revise GSPV documents, including but not limited to: GSPV SOPs/WIs, PSMF, SDEA's, other GSPV related documents and policies
• Develop and monitor quality control parameters for GSPV processes and assume responsibility for ensuring internal reviews and quality checks are performed and documented
• Develop, monitor, and assess compliance metrics to ensure compliance goals are met
• Establish and maintain Pharmacovigilance inspection readiness in collaboration with GSPV subject matter experts (SMEs) and Clinical Quality Assurance; function as company's representative during regulatory agency inspections and vendor audits; author responses to audit/inspection findings relevant to functional area
• Support strategic direction with cross functional working groups to identify and mitigate GSPV quality and compliance gaps/issues/risks
  
  

Function as operational lead for case management, including but not limited to vendor oversight, forecasting, budgeting, compliance, key performance indicators, and training, as applicable

• Author and maintain various pharmacovigilance documents, including but not limited to safety management plans, safety data exchange agreements, safety handling plans, or business partner contracts or agreements and memorandum, as applicable.
• Oversee and monitor activities of vendors/CROs/business partners to ensure adherence and compliance with applicable study protocols, Safety Management Plans, SOPs and WIs, defined metrics, and contractual agreements
• Lead GSPV training curricula development and maintenance in conjunction with Clinical Quality Assurance
• Develop, review, maintain, and revise relevant GSPV document templates (e.g., SAE report forms, safety data entry guidelines, DSURs, etc.).
• Monitor industry best practices, changes in global safety regulations and guidances and, based on changes, develop and/or modify to departmental plans, policies, and procedures, as needed
• Supervise and provide oversight of operations personnel (direct reports, consultants, and vendors) including mentoring, training, and monitoring compliance, as applicable
• Other duties as assigned
  
  

Requirements

Education and Experience:

• Master's degree in a relevant field (Life sciences), nursing degree, or pharmacy degree required; for exceptional candidates, a Bachelor of Science Degree in Life Sciences (nursing or pharmacy) combined with relevant experience will be considered
• A minimum of 8-10 years of experience in pharmacovigilance with a focus on operations, across clinical trial and post-marketed phases, is required
• Role requires a successful proven-track record of 2-4 years experience in a similar role
• Experience with effectively managing regulatory agency inspections and working with regulators and internal staff to help prepare for inspections; experience with preparation of responses to audits/inspections, including corrective and preventative actions
• Strong knowledge and understanding of drug, device, and vaccine FDA, EU, and ICH regulations, pharmacovigilance regulations/processes, and HA inspection procedures is required
• Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice
• Demonstrate ability to provide critical and timely insight, and analytical critical thinking skills with a broad perspective
• Proven experience with currently available drug safety database systems (Argus preferred), document management systems and QC tools, including MedDRA and WHODrug coding experience
  
  

Competencies and Attributes:

• Requires demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena's culture and values – courageous, imaginative, selfless, and joyful
• The position demands excellent people skills, independent decision-making, and flexibility to adapt to a fast-paced, dynamic, and complex regulatory and business environment
• Strong collaborator who is solution oriented and has a customer service approach
• Ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop and drive realistic plans, programs, and recommendations
• Strong attention to detail and the ability to work independently, as well as within a multi-disciplinary team and with external partners and vendors
• This position requires a commitment to process improvements, excellent organizational skills, excellent written and verbal communication skills, a strong commitment to best practices, and the ability to work effectively as both a functional area manager as well a cross-functional project team member
• Demonstrated ability; excellent analytical skills, an ability to communicate complex issues in a straightforward way and to orchestrate plans to resolve issues and mitigate risks
• Computer literacy is essential
  
  

Compensation Overview:

The anticipated annual salary range for this role is $205,000 to $281,000. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. The final salary offered to a successful candidate will be dependent on several factors that may include – but are not limited to – the final job level offered, the type and length of experience within the job and industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.

The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.

Health & Wellness Benefits, 401(k) and PTO Overview:

• All Prothena employees (and their families) are covered by medical, dental, and vision insurance, with Prothena paying ~90% of plan premiums.
• Prothena pays the full premium for basic life and disability insurance for all employees.
• Prothena employees are also eligible to enroll in our Company's 401(k) plan and are always 100% vested in their account balances. The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings, as well as an additional, annual discretionary Company match of up to 2% of eligible earnings.
• New Prothena employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays – which includes a Company-wide shutdown at the winter holidays.
  
  

More information about Prothena can be found at the Company's website: www.prothena.com.