Senior Director, Pharmacovigilance (pv) Scientist

Job Summary:              

This person reports to the Executive Director, Drug Safety & Pharmacovigilance (DSPV) and supports both early and late-phase development activities. PV Scientist 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 Scientist 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:

• Build scientific function of safety surveillance and aggregate safety reports, author safety signal assessment reports and aggregate safety 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 detect, and benefit-risk assessment for Keros products, prepare the meeting minutes, and track actions
• Compile safety information for aggregate safety reports in support of periodic safety data review meetings.
• Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment in collaboration with the Head of DSPV and safety physicians
• Review and communicate trending, signaling, and other safety-related issues originating from any source for the purposes of detecting and reviewing safety signals (e.g., change in frequency, nature, or severity of a safety-related issue) in a timely manner
• Review potential issues and safety signals and contribute to the Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic / aggregate safety data reviews, and provide recommendations for review and approval by the Safety Management Team (SMT).
• Lead across cross-functional teams to generate cross-functional safety documents such as DSUR and RMP
• Author safety-related documents for Keros products throughout product lifecycle from FIH to post-marketing, including Similar Case Analysis, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g., DSUR, PBRER, PSUR, PADER), RMP/developmental RMP, and responses to ad-hoc requests for safety information internally and externally
• Provide safety data and review IND Annual Reports in collaboration with other stakeholders
• Review SMP, and provide input to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), and other relevant documents
• Provide oversight of MedDRA and WHO Drug coding
• 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
• Document Control: maintain electronic files for relevant DSPV documents on the Keros SharePoint or shared drives or other system
• Assist department head to facilitate department meetings; prepare agendas and meeting minutes; assist with vendor management and oversight
• 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 to meet required deadlines

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