Medical Director, SERM, Clinical Safety, Pharmacovigilance

Alphanumeric Systems

. Lead safety evaluation and benefit-risk assessments for assigned products .

Posted 9/29/2026full-timeRemote • BrazilLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading safety evaluations and benefit-risk assessments, with a strong background in pharmacovigilance and regulatory submissions. Proficient in scientific writing and communication, with the ability to analyze clinical data and interact with global regulatory agencies.

Highest-signal resume keywords

MD Or Equivalent Physician QualificationClinical Development ExperiencePharmacovigilance ExpertiseRegulatory Submission SupportHealth Authority Interaction Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety EvaluationBenefit-Risk AssessmentClinical Data AnalysisScientific WritingRegulatory Submission Preparation

Soft Skills

Excellent Communication SkillsAbility To Work IndependentlyAdaptability In Fast-Paced Environments

Industry Keywords

Pharmaceutical FunctionsOncology ExperienceFDA InteractionEMA InteractionPMDA Interaction

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

1-Year Contract with potential extension