Medical Director (SERM & Clinical Safety & Pharmacovigilance)

About the role

Alphanumeric Systems is seeking a Medical Director to lead Safety Evaluation & Risk Management (SERM) for a major global pharmaceutical client. This is a remote, 1‑year contract position based in Portugal, with the possibility of extension. The role provides medical leadership across clinical development and post‑marketing safety activities.

Key responsibilities

• Lead safety evaluation and benefit‑risk assessments for assigned products.
• Support pharmacovigilance and risk‑management activities throughout the product lifecycle.
• Prepare scientifically sound responses to Health Authority Requests for Information (RFIs) and contribute to regulatory submissions.
• Analyze clinical and safety data to inform regulatory and business decisions.
• Participate in cross‑functional safety governance and product safety discussions.

Required profile

• MD or equivalent physician qualification.
• Significant experience in clinical development, drug safety, or pharmacovigilance.
• Proven experience responding to Health Authority RFIs and supporting regulatory interactions.
• Excellent scientific writing and communication skills in English.
• Ability to work independently in a fast‑paced, matrixed environment.

Required skills

• Pharmacovigilance
• Benefit‑risk assessment
• Regulatory submissions
• Scientific writing

What we offer

• 120,000 EUR annual salary plus benefits.
• 100 % remote work model.
• Full‑time schedule with flexibility to align with U.S. and/or U.K. business hours.