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Scientific Director – Clinical Safety, Pharmacovigilance
Alphanumeric Systems. Provide scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance, safety evaluation, and regulatory submissions, with a strong focus on risk management and cross-functional collaboration. Proficient in scientific writing and communication, with the ability to support clinical development teams effectively.
Highest-signal resume keywords
PharmacovigilanceRegulatory SubmissionsSafety Data EvaluationHealth Authority InteractionsClinical Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical DevelopmentDrug SafetyRisk ManagementScientific WritingData AnalysisProtocol SupportOncology ExperienceRegulatory ExperienceEmerging Safety ConcernsCross-Functional Collaboration
Soft Skills
Analytical SkillsCommunication SkillsIndependent WorkEscalation of IssuesTeamwork
Certifications & Qualifications
Advanced Scientific Degree
Industry Keywords
FDAEMAPMDAHealth Authority Requests for InformationBenefit-Risk ManagementPost-Marketing ProgramsSafety GovernanceGlobal Development Programs
About the role
Key responsibilities & impact- Provide scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs
- 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
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
Benefits
Comp & perks- 1-Year Contract with potential extension
- Remote work arrangement
- Ability to work within U.S. and/or U.K. business time zones