Elevar Therapeutics · 1 day ago
Senior Director, Drug Safety and Pharmacovigilance (Remote)
United States
Full-time
Remote
Director/Executive
$299K/yr - $340K/yr
10+ years expElevar Therapeutics is a rapidly growing biotech company, and they are seeking a Senior Director, Drug Safety and Pharmacovigilance. This role is responsible for identifying and managing safety concerns with drug products, ensuring safety signals are appropriately evaluated and communicated, and overseeing drug safety activities in clinical development and post-marketing surveillance.
BiotechnologyHealth CareMedicalPharmaceuticalProduct DesignTherapeutics
Responsibilities
Responsible for providing oversight and management of activities pertaining to Elevar’s product safety and pharmacovigilance in clinical development and post-marketing surveillance
Oversee and is responsible for the integration of pre-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated and proactive approach to risk management
Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment and clinical trial data interpretation
Ensure processes within DSPV are conducted in accordance with corporate Standard Operating Procedures (SOPs), department SOPs, guidelines and applicable regulations
Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
Chair for the Drug Safety Council, Safety Data Review Team, and Safety Management Team meetings and participate in Joint Safety Meetings with partners
Oversee development and compliance of Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements (PVA) with partners
Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues, including contributing authorship and review of Investigator Brochures, development plans, clinical protocols, INDs/CTAs, regulatory responses and risk management plans. (e.g. Clinical Safety Reports, NDAs, Integrated Summary of Safety, etc.)
Support and/or draft regulatory inquiry responses related to DSPV issues to regulatory agencies, EC/IRB, Investigators and ad hoc inquiries
Provide oversight and input to aggregate safety reports (e.g. development safety update reports, periodic benefit risk evaluation reports) as appropriate for DSPV relevance
Manage literature searches and review and able to effectively determine appropriate and relevant literature for safety analyses in collaboration with the Safety Scientist
Support the conduct of DSPV internal & external audits and regulatory inspections and ensure audit and inspection readiness of the function at all times
Qualification
Required
MD or DO is required
Minimum of 10 years in drug safety activities is required with both Clinical and Post-Marketing PV Physician experience, oncology experience preferred
Proven strategic management experience demonstrating business acumen, developing and delivering strategy and vision, delivering results, championing innovation, coaching and developing subordinates, including remote teams
Experience in communicating with the FDA. Working knowledge of relevant FDA, EU, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both safety reporting and processing for clinical trial environments
Strategic management experience, delivering results, championing innovation, coaching and developing individuals and teams in person and remotely
Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
Working knowledge of MedDRA dictionary and WHO Drug Dictionary. Experience with MedDRA coding, Analysis of Similar Events, and Standardized MedDRA Queries (SMQs)
Experience with Argus safety databases
Knowledge of Individual Case Safety Reports (ICSR) management processes
Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a remote team
Management experience as this position has direct reports
20% travel is required
Ability to demonstrate Elevar's core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making spaces for ingenuity in work and thought, and staying grounded in compassion
Preferred
Oncology experience preferred
Benefits
Medical
Dental
Vision
Time off
A retirement plan
Other voluntary benefits for employees
Company
Elevar Therapeutics
Elevar Therapeutics specializes in clinical development of promising therapies for unmet medical needs in cancer.
11-50 employees
H1B Sponsorship
Elevar Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Early StageTotal Funding
$20M2018-07-25Series Unknown· $20M
Leadership Team
Kenneth Rankin
Vice President of Market Access
Recent News
Elevar Therapeutics
2025-12-03
Company data provided by crunchbase