Position Overview:

In conjunction with the Senior Director, Head of Safety Science performs safety surveillance activities and provides scientific/clinical/pharmacovigilance expertise for safety data analysis from various sources including pre-clinical studies, clinical studies, literature, and other information sources. The SSL will focus on the pro-active identification, evaluation, and risk management of safety risks to patients for assigned Prothena portfolio compounds throughout the entire product lifecycle.

Responsibilities:

• In conjunction with the Safety Physician, support proactive Pharmacovigilance signal detection and risk management planning for designated Prothena products, including signal identification, evaluation, interpretation of safety signals and trends and communication (written and verbal) of safety risks and prepare scientifically accurate documents and presentations to communicate pertinent safety information.
• Prepares and authors reports of aggregate safety data such as DSURs, 6 monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS) and EU Risk Management Plans.
• Authors pharmacovigilance responses in multiple cross-functional FDA pre-inspection requests and safety contribution to cross-functional briefing book for FDA regulatory filings. Other relevant documents may include the following:
  • Safety signal assessments
  • Labeling justification documents; safety updates to company Core Data Sheets and local reference safety information labels.
  • Ad hoc safety queries and Periodic Aggregate Safety Reports
• Key member of the Safety Governance Committee including setting agenda, producing necessary data outputs, facilitating discussions, and documenting conclusions
• Prepares and maintains Reference Safety Information (RSI) and product labeling (e.g., Developmental Core Safety Information (DCSI), Company Core Safety Information (CCSI), Investigator Brochure (IB), etc.)
• Coordinates and authors responses for regulatory or other ad-hoc safety queries in collaboration with safety physician – includes proposing response strategies, review of relative data, and authoring of responses.
• Collaborates with other applicable functional area specialists including Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Contract Research Organization (CROs), Data Monitoring Committees (DMCs) and other entities, as needed, to evaluate and manage safety signals for Prothena compounds.
• Provides support to cross-functional ad-hoc teams set up to address urgent and important safety issues. Participate in safety surveillance and design of post-marketing studies and Phase IV commitments, if applicable.
• Demonstrates knowledge and ensuring compliance with current and applicable global PV regulations/guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.) and with corporate and departmental policies and procedures.
• Synthesizes data from multiple sources and critical thinking skills as well as authoring monthly signaling reports; accountable for maintaining personal readiness in response to internal audit or regulatory inspection
• Mentor Global Safety Officers and Global Pharmacovigilance Scientists on all aspects of safety.

Requirements:

Education and Experience:

• Applicants must meet the following requirements: minimum of a bachelor's degree in Nursing, Pharmacy, Biosciences, or other health-related field and a minimum of 2 years of clinical experience; pharmaceutical industry experience (10+ years) in Global Safety Leader/Safety Scientist/PV Risk Management role.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical/pharmaceutical information and safety data and developing risk management/mitigation strategies; experience in the preparation and authoring of aggregate safety reports, RMPs and RSI.
• Ability to apply principles, concepts and industry best practices governing pharmacovigilance and risk management in assigned projects; excellent verbal and written communication skills as well as presentation and team-interaction skills are necessary; proven leadership ability to drive cross-functional teams for decision making.
• Proficiency in Microsoft Office; efficient in time management and multi-tasking; and strong organizational skills, including the ability to prioritize independently with minimal supervision.

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.

Compensation Overview:

The anticipated annual salary range for this role is $265,000 to $335,000. 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.