Director, Global Safety and Pharmacovigilance

Position Overview:

The Director Global Safety and Pharmacovigilance (GSPV) is responsible for pharmacovigilance activities involving the Company's investigational products and clinical trials. The Director, GSPV will manage individual serious adverse event (SAE) cases, including review, processing, and evaluation of safety reports. Additional duties include participating in the safety surveillance activities for investigational products, supporting the management of the operational function and representing GSPV at a cross functional level. The Director, GSPV is accountable for ensuring effective, high quality and efficient management of resources, processes, and cases to comply with global regulatory reporting timelines.

Responsibilities:

• Oversee the proper and timely collection and reporting of SAE information from all sources
• Collaborate with other functional areas to maintain an effective and compliant system to monitor the benefit-risk profile of Prothena products
• Assist in ensuring accurate preparation and management of individual case summary reports (ICSRs) (e.g. IND safety reports) and aggregate safety reports (e.g. DSURs, PSLLs, etc.) in compliance with internal procedures and regulatory reporting requirements and timelines
• Oversee the review of clinical trial SAEs and queries from a medical perspective, and interface with reporters, as appropriate
• Ensure safety-related start-up activities are completed prior to subject enrollment
• Provide support for safety sections of clinical documents, including the review of safety portion of protocols, ICFs, IBs, and other relevant documents, as applicable
• Review of study-specific case report forms, data entry guidelines, as requested
• Contribute to planned and ad hoc regulatory authority submissions by reviewing safety data and assisting in the preparation of relevant sections
• Monitor industry best practices, changes in global safety regulations and guidances for investigational products and develop and/or modify to departmental plans, policies, work instructions, and SOPs, as needed
• Create and track case processing metrics for internal monthly safety reports
• Management of workload and resources for safety team to meet global regulatory timelines
• Supervise operations personnel (direct reports, consultants, and vendors) including mentoring, training, and monitoring compliance
• Delegate responsibilities to direct reports, as applicable, and oversee completion of tasks
• Coordinate and chair regular Safety team meetings, as applicable
• Participate in regulatory and inspections/audits related to pharmacovigilance activities, including authoring of responses to findings relevant to functional area
• Collaborate cross-functionally with other departments including, but not limited to, Clinical Development, Data Management, Biostatistics, Clinical Operations and Regulatory Affairs with respect to safety related issues
• Provide oversight of drug safety vendors processes
• Responsible for the oversight, management and communication of global business partner safety data exchange agreements and other contracts, as applicable, to ensure compliance with data exchange
• Assist in budget planning and management (e.g. for assigned studies)
• Other duties as assigned

Requirements:

Education and Experience:

• Advanced degree in life sciences, nursing, pharmacy, or medicine; PhD, PharmD, RN.
• Minimum 8 years’ experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 1-3 years of functional management experience overseeing PV staff/contractors
• A thorough understanding of the global PV regulatory environment with working knowledge of US and EU regulations, ICH guidelines, and GCP; a working understanding of drug safety databases, effective project management skills; a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
• Thorough knowledge of the clinical drug development process and experience in all aspects of global safety reporting from clinical trials through commercialization
• Proven experience with currently available drug safety database systems, document management systems, and QC tools, including MedDRA and WHODrug coding experience
• Operational expertise with safety databases such as ARGUS is preferred

Competencies and Attributes:

• 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 interpersonal skills, decision-making, and ability to adapt to a fast-paced, dynamic, and complex regulatory and business environment
• Strong team player who has a customer service approach and is solution oriented
• 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
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as 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 as cross-functional project team member
• Demonstrated ability to translate strategy into action; excellent analytical skills, an ability to communicate complex issues in a simple 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 at Director level is $215,000 to $280,000. 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.