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

About the role

Alphanumeric is looking for a SERM Scientific Director to support a global Safety Evaluation and Risk Management organization. The role provides scientific leadership in product safety evaluation, benefit-risk management and pharmacovigilance across clinical development and post-marketing programs. It is fully remote, based in Portugal, on a full-time 1-year contract with potential extension.

Key responsibilities

• 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, including drafting and reviewing responses to Health Authority RFIs
• Provide protocol, safety and regulatory support to clinical development teams
• Take part in cross-functional safety governance and risk management activities
• Identify emerging safety concerns and recommend actions

Required profile

• 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 RFIs and strong protocol and regulatory experience
• Proficiency in English is mandatory
• Ability to work independently and escalate issues when needed
• Expertise in classic established products, oncology, respiratory, immunology, inflammation, vaccines and infectious disease is requested

Required skills

• Excellent analytical, scientific writing and communication skills
• Strong protocol support and regulatory experience
• Experience in global cross-functional teams
• Oncology experience and experience with FDA, EMA, PMDA and other regulators are preferred

What we offer

• Salary base of 95,000 to 105,000 EUR gross per year
• Fixed teleworking compensation of 50 EUR gross plus health insurance for the worker