Medical Director – SERM, Clinical Safety, Pharmacovigilance

Alphanumeric Systems

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

Posted 10/8/2026full-timeRemote • PortugalLead💰 €120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading safety evaluations and benefit-risk assessments, with a strong focus on pharmacovigilance and regulatory submissions. Proficient in scientific writing and communication, with the ability to analyze clinical data to inform regulatory and business decisions.

Highest-signal resume keywords

MD Or Equivalent Physician QualificationClinical Development ExperiencePharmacovigilance ExpertiseRegulatory Submissions 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 Support

Soft Skills

Excellent Communication SkillsAbility To Work IndependentlyAdaptability In Fast-Paced Environments

Industry Keywords

Pharmaceutical FunctionsHealth Authority Requests For InformationFDA InteractionEMA InteractionPMDA InteractionOncology Experience

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 Requests for Information (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
Availability to work within U.S. and/or U.K. business time zones
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

Potential contract extension
100% from home / remote work