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About the role:
- Alphanumeric is seeking a SERM Scientific Director to support a global Safety Evaluation & Risk Management organization.
- The role provides scientific leadership in product safety, benefit-risk management, and pharmacovigilance across clinical development and post-marketing programs.
Key Responsibilities:
- Lead safety review and risk management activities for assigned products.
- Provide protocol, safety, and regulatory support to clinical development teams.
- Draft and review responses to Health Authority Requests for Information (RFIs).
Required Qualifications:
- 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.
- Excellent analytical, scientific writing, and communication skills; proficiency in English is mandatory.
Preferred Qualifications:
- Oncology experience is highly desirable but not required.
- Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.
Alphanumeric
Alphanumeric is a company that provides scientific and clinical safety expertise, supporting global organizations in pharmacovigilance and risk management. The company culture emphasizes independent work and collaboration across global teams.