Enliven Therapeutics · 9 hours ago
Director, Safety Operations
United States
Part-time
Remote
Director/Executive
$205K/yr - $255K/yr
5+ years exp
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Responsibilities
Oversee the duties and responsibilities performed by Data Safety Pharmacovigilance (DSPV)
Physician and Pharmacovigilance (PV) Operations consultants, and full service DSPV service provider(s) handling activities such as case-processing, submissions, and safety database hosting.
Leads the implementation and oversight of the procedures performed by service provider(s) regarding the receipt, processing, management, and reporting of individual safety case reports (ICSRs) to ensure compliance with corporate and regulatory requirements.
Accountable for oversight of any safety-related activities carried out by service provider(s) on Enliven Therapeutics behalf.
Assesses the vendor’s service quality, compliance, and performance in a risk-based manner as it impacts the PV System and in compliance with applicable laws, regulations, and Good Pharmacovigilance (GVP) provisions.
Leads the development of the study specific safety management plans (SMPs) with service provider(s) and partners.
Responsible for contractual agreements of pharmacovigilance vendors (e.g. PVA/PVMP/SMP) and partners (SDEA)
Monitors metrics/key performance indicators (KPIs) to assess service provider(s)’ performance and compliance with the requirements of the SMPs and/or contracts.
Collaborates with DSPV Physician on development and implementation of signal detection plan
Leads the establishment, implementation, and management of the Safety Surveillance Executive Committee (SSEC) and their activities, including activities that monitor safety signals and mitigation plans to promote patient safety and compliance with global safety regulations.
Conduct safety data review and analysis, summarize safety data in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities
Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities
Collaborate with DSPV Physician and Clinical Development to develop and maintain Core Safety Information/Reference Safety Information, as appropriate, and communicate identified risks to applicable internal and external stakeholders, as appropriate
Provide oversight and assist in preparation and review of key pharmacovigilance document such as Drug Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Reports, Periodic Safety Update Reports, Risk Management Plans and safety sections of Investigator Brochures (IB), Informed Consent Forms (ICF) and clinical trial/study protocols and final reports in accordance with legal requirements, respective SOPs, and Health Authority expectations
Perform gap analysis of the DSPV function/department to establish procedures, SOPs, and/or roles for the DSPV infrastructure.
Experience with (Argus) safety database establishment and implementation
Support SAE reconciliation activities for all Enliven Clinical Trials
Overall responsibility for the quality and compliance of DSPV processes and PV system
Lead Regulatory Inspections for PV Operations and Risk Management activities
Qualification
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Required
Advanced Degree: Minimum of 5+ years of experience in drug safety operations, ideally within the oncology therapeutic area with small molecule experience
Vendor Management Expertise: Proven experience in overseeing and managing safety vendors is essential
Technical Proficiency: Strong expertise in utilizing safety databases and safety coding dictionaries
Global Safety Reporting: In-depth knowledge of international safety reporting regulations and best practices
Regulatory Acumen: Comprehensive understanding of and ability to implement pre- and post- marketing drug safety standards, particularly in oncology
Communication Skills: Exceptional oral and written communication skills, enabling clear and effective information exchange
Team Collaboration: Strong interpersonal skills with a demonstrated ability to work collaboratively within cross-functional teams
Project Management: Ability to manage multiple projects and meet tight deadlines with a high degree of accuracy and efficiency
Strong ethics to approach programs with thoughtful and practical solutions
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Company
Enliven Therapeutics
Enliven Therapeutics is a precision oncology company developing small molecule therapies to extend and improve patient lives.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$230M2024-03-19Post Ipo Equity· $90M
2023-02-24IPO· undefined
2022-01-19Series B· $85M
Leadership Team
Sam Kintz
Co-Founder and CEO
Anish Patel
Co-Founder and COO
Recent News
2024-06-05
Investing.com
2024-06-05
Company data provided by crunchbase
