Senior Director, Pharmacovigilance (PV) Sciences

Job Summary:              

The Senior Director, Pharmacovigilance (PV) Sciences serves as the vital bridge between scientific strategy and operational drug safety for the company's early-stage and clinical pipeline. In this hybrid, hands-on role, you will be responsible for both strategic safety science and daily PV operations. You will report directly to the Vice President, Head of Clinical Development & Operations (a former PV physician and Head of Drug Safety).

The Senior Director, Pharmacovigilance (PV) Sciences partners with PV physicians, other clinical development colleagues, and PV vendors, and will contribute to safety deliverables required to manage and communicate the evolving safety profile of Keros products. The Senior Director, PV Sciences is responsible for safety surveillance and aggregate safety reports and works with PV physicians for signal/risk management for Keros products to support product safety and compliance with global drug safety regulations and functional procedures and provide vendor oversight to PV vendors. The individual authors safety documents, reviews safety sections of other documents for Keros products throughout the product lifecycle, performs QC and maintains document control of safety documents. This individual will organize cross-functional Safety Management Team meetings and collaborate with colleagues in Clinical Development, Clinical Pharmacology, Biometrics, Regulatory, Medical Affairs, Toxicology and non-clinical safety, QA, and Legal functions. This individual ensures compliance with all applicable US and foreign legal and regulatory requirements for signal detection, evaluation & risk management of products.

Primary Responsibilities:

• Serve as the primary liaison with external PV vendors, Contract Research Organizations (CROs), and safety database providers. Ensure database readiness and compliance with global regulatory guidelines
• Develop scalable PV systems and processes as the company transitions its clinical pipeline
• Proactively establish and maintain inspection readiness for Health Authority audits
• Lead proactive signal detection, evaluation, management, author safety signal assessment reports, write and maintain relevant SOPs and procedures in compliance with global safety regulations and guidelines, and provide training within DSPV and cross-functionally
• Lead and manage all medical safety and risk management related projects including planning, tracking and execution; provide vendor oversight for quality of ICSRs, similar case analysis, and aggregate safety reporting; lead initiatives from the scientific and PV regulation perspective such as inspection readiness, and launch readiness
• Organize and facilitate cross-functional Safety Management Team (SMT) meetings for signal management, risk management detection, and benefit-risk assessment for Keros products, prepare the meeting minutes, and track actions
• Spearhead the planning, writing, and review of key periodic and aggregate safety reports
• Review safety concerns escalated from internal and external stakeholders, including competent Regulatory Authorities, and develop strategies for safety assessment in collaboration with PV physicians
• Provide scientific and medical input into clinical documents such as Protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs) and responses to ad-hoc requests for safety information internally and externally
• Tailor benefit-risk assessments and risk mitigation strategies to the specific physiological, developmental, and regulatory realities of pediatric populations
• Schedule meetings for safety teams, clinical teams and vendors for follow-up queries and company causality assessment for SAEs, pregnancy and special cases in clinical trials
• Perform QC (quality control) for multiple tasks and data reconciliation of between the Clinical and the Safety Database
• Provide strategic safety contributions to regulatory submissions (e.g., INDs, eventual NDAs/BLAs).
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
• Other duties as assigned

Qualifications:

• Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 8-10+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments
• Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
• Skilled in signal detection process and managing safety information from clinical development and post-marketing sources
• Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
• Excellent verbal and written communication skills with ability to write clearly and concisely, and strong presentation skills
• Ability to be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment
• Time management skills with ability to prioritize meeting required deadlines