Scientific Director (SERM & Clinical Safety & Pharmacovigilance) - Remote

About the role

Alphanumeric Systems is seeking a Scientific Director to lead its SERM, Clinical Safety and Pharmacovigilance activities within a global Safety Evaluation & Risk Management organization. The role provides scientific leadership across clinical development and post‑marketing programs, ensuring robust safety evaluation and benefit‑risk management.

Key responsibilities

• Lead safety review and risk‑management activities for assigned products, evaluating data from clinical trials, post‑marketing sources and scientific literature.
• Support global regulatory submissions and interact with health authorities, drafting and reviewing responses to Requests for Information (RFIs).
• Provide protocol, safety and regulatory support to clinical development teams and participate in cross‑functional safety governance.
• Identify emerging safety concerns, recommend appropriate actions and ensure scientifically sound, compliant safety strategies.

Required profile

• Advanced scientific or healthcare‑related degree (PhD, PharmD, MS, NP, RN or equivalent).
• Significant experience in clinical development, drug safety, pharmacovigilance or related field.
• Proven experience responding to Health Authority RFIs and supporting regulatory submissions.
• Strong analytical, scientific writing and communication skills; proficiency in English.
• Ability to work independently, manage safety issues and appropriately escalate when needed.