Scientific Director – SERM, Clinical Safety, Pharmacovigilance

Alphanumeric Systems

. Lead safety review and risk management activities for assigned products .

Posted 9/29/2026full-timeRemote • BrazilLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in safety review, risk management, and pharmacovigilance, with a strong background in clinical development and regulatory submissions. Capable of providing scientific leadership and collaborating effectively with cross-functional teams to ensure compliance and sound safety strategies.

Highest-signal resume keywords

Clinical Development ExperiencePharmacovigilance ExpertiseRegulatory Submission SupportHealth Authority InteractionAnalytical and Scientific Writing Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety ReviewRisk ManagementData EvaluationProtocol SupportRegulatory ExperienceBenefit-Risk ManagementPharmacovigilanceClinical Trials AnalysisEmerging Safety Concerns IdentificationStrategic Decision-Making

Soft Skills

Excellent Communication SkillsAbility to Work IndependentlyCollaboration with StakeholdersEscalation of Issues

Certifications & Qualifications

Advanced Scientific DegreeHealthcare-Related Degree

Industry Keywords

FDAEMAPMDAOncologyGlobal Regulatory AgenciesHealth Authority Requests for InformationPost-Marketing ProgramsCross-Functional Teams

About the role

Key responsibilities & impact

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 appropriate actions
Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies
Provide scientific leadership in product safety evaluation, benefit-risk management, and pharmacovigilance across clinical development and post-marketing programs
Independently manage safety issues and contribute to strategic safety decision-making across global programs

Requirements

What you’ll need

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 Requests for Information (RFIs)
Strong protocol support and regulatory experience
Excellent analytical, scientific writing, and communication skills
Proficiency in English is mandatory
Ability to work independently and appropriately escalate issues when needed
Experience working effectively within global cross-functional teams
Oncology experience is highly desirable but not required
Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies
Experience supporting global development programs
Availability to work within U.S. and/or U.K. business time zones

Benefits

Comp & perks

1-Year Contract with potential extension
Remote work arrangement based in Brazil