Medical Director, SERM, Clinical Safety, Pharmacovigilance

🔥 0 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 10%

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Alphanumeric Systems

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1979

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Alphanumeric Systems is a healthcare and life-sciences communications and services firm that provides medical and scientific communications, regulatory writing and submission support, pharmacovigilance, contact center and patient engagement services, KOL engagement, and facilities management and space optimization for pharmaceutical and biotech clients. The company delivers compliance-driven, omnichannel outreach and learning solutions with global reach to support therapy launches, patient access programs, HCP collaboration, and ongoing patient care.

📋 Description

• Lead safety evaluation and benefit-risk assessments for assigned products • Support pharmacovigilance and risk management activities across clinical development and marketed products • Contribute to regulatory submissions and health authority interactions • Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs) • Analyze and interpret clinical and safety data to support regulatory and business decisions • Participate in cross-functional safety governance and product safety discussions • Provide protocol and regulatory support throughout the development lifecycle • Escalate significant safety concerns and emerging risks when appropriate

🎯 Requirements

• MD or equivalent physician qualification • Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions • Experience responding to Health Authority RFIs • Strong understanding of benefit-risk assessment and safety evaluation • Experience supporting regulatory submissions and regulatory authority interactions • Excellent scientific writing and communication skills • Proficiency in English is mandatory • Ability to work independently in a fast-paced, highly matrixed environment • Oncology experience is highly desirable but not required • Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies • Experience supporting global development programs

🏖️ Benefits

• 1-Year Contract with potential extension