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

About the role

A global Safety Evaluation and Risk Management organization is looking for a SERM Scientific Director, working remotely and based in Brazil. The role provides scientific leadership in product safety evaluation, benefit-risk management and pharmacovigilance across clinical development and post-marketing programs. It suits a strong scientific leader who can manage safety issues independently, support regulatory activities and contribute to strategic safety decisions. The position is full-time on a 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
• 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 actions
• Collaborate with internal stakeholders on scientifically sound and 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 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
• Experience in global cross-functional teams; oncology experience is highly desirable but not required

Required skills

• Excellent analytical, scientific writing and communication skills
• Therapeutic area expertise in classic established products, oncology, respiratory, immunology, inflammation, vaccines and infectious disease
• Experience with FDA, EMA, PMDA and other global regulators is preferred