Lifelancer · 16 hours ago
Sr. Director/Safety Scientist, Pharmacovigilance Operations
United States
Full-time
Remote
Director/Executive
$248K/yr - $285K/yr
10+ years expLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. They are seeking a Sr. Director/Safety Scientist for Pharmacovigilance Operations who will oversee all aspects of the assigned product’s safety profile, manage CROs, and collaborate on safety strategies for marketing authorization applications.
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Responsibilities
Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data
Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data
In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries
Support the clinical development team in the review of key documents, including protocols and informed consent forms (ICFs)
Manage drug safety contract research organizations (CROs) for clinical programs to ensure compliance with expedited reporting requirements, on-time and scientifically sound DSUR preparation, and alignment with corporate goals and KPIs
Assist in the medical review of adverse event reports; manage preparation and submission of expedited safety reports in compliance with global regulations, when necessary
Develop and prepare assessments of safety data, safety signals, and benefit-risk evaluations for internal senior management as well as external partners and regulatory authorities
Assist in the authoring of aggregate safety reports
Qualification
Required
Bachelor's degree in a healthcare discipline or equivalent is required
Minimum of ten years of drug safety and pharmacovigilance experience, including at least five years in clinical development safety
Extensive experience with all aspects of safety signal evaluation, including data review and analysis, cross-functional collaboration, authoring regulatory correspondence, and safety label updates
Experience in both clinical development and post-marketing safety
Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements
Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitoring, clinical operations, biostatistics, regulatory affairs, medical writing, and quality assurance
Experience managing clinical safety aspects of product quality defect investigations and assessments
Familiarity with clinical trial safety databases and CIOMS II and DSUR reporting (e.g., Argus, ArisG, or Veeva Safety) and proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook)
Preferred
An advanced degree is preferred
Experience with regulatory submissions for NDAs, EU MAAs, and other global regulatory reviews is highly preferred
Experience in drug safety audits and regulatory agency inspections
Benefits
401(k) with 100% employer match on the first 3% and 50% match on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with a $2,500 award for hired referrals
Comprehensive health coverage with 100% of premiums covered for employees and dependents
Mental health support via Spring Health (6 therapy sessions and 6 coaching sessions)
Hybrid work model with flexibility in where and how work is performed
Unlimited flexible paid time off
Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents
Flexible spending accounts and company-provided group term life and disability insurance
Subsidized lunches via Forkable on in-office days
Opportunities for growth from discovery through late-stage development and FDA pipelines
Career pathing through regular feedback, professional development programs, and continuous education via LinkedIn Learning, LifeLabs, Spring Health, and BetterUp Coaching
Recognition of strong performance through financial rewards, peer recognition, and advancement opportunities
Company
Lifelancer
Lifelancer is a global platform for talent hiring in Life Sciences, Pharma, Healthtech & IT
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.68M2025-03-01Pre Seed· $0.24M
2024-03-01Pre Seed· $0.11M
2023-03-01Pre Seed· $0.12M
Leadership Team
J
Jayesh Pandya
Co-Founder & CEO
Company data provided by crunchbase