Scientific Director – Clinical Safety, Pharmacovigilance
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Job Description
Scientific Director leading product safety, benefit-risk management, and pharmacovigilance for Alphanumeric’s global clinical and post-marketing programs. Supporting regulatory submissions and safety governance.
Responsibilities:
- Provide scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs
- Lead safety review and risk management activities for assigned products
- Evaluate safety data from clinical trials, post-marketing sources, and scientific literature
- Support global regulatory submissions and health authority interactions
- Draft and review responses to Health Authority Requests for Information (RFIs)
- Provide protocol, safety, and regulatory support to clinical development teams
- Participate in cross-functional safety governance and risk management activities
- Identify emerging safety concerns and recommend appropriate actions
- Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies
Requirements:
- Advanced scientific or healthcare-related degree (PhD, PharmD, MS, NP, RN, or equivalent)
- Significant experience in clinical development, drug safety, pharmacovigilance, or a related field
- Experience responding to Health Authority Requests for Information (RFIs)
- Strong protocol support and regulatory experience
- Excellent analytical, scientific writing, and communication skills
- Proficiency in English is mandatory
- Ability to work independently and appropriately escalate issues when needed
- Experience working effectively within global cross-functional teams
- Oncology experience is highly desirable but not required
- Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies
- Experience supporting global development programs
Benefits:
- 1-Year Contract with potential extension
- Remote work arrangement
- Ability to work within U.S. and/or U.K. business time zones
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