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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in signal detection and evaluation, with a strong background in safety surveillance and risk management within the pharmaceutical industry. Proficient in applying FDA, EU, and ICH guidelines to pharmacovigilance activities and effectively communicating safety findings.
Highest-signal resume keywords
Signal Detection ActivitiesSafety Evaluation ReportsRisk Management ExperiencePharmacovigilance GuidelinesSafety Data Manipulation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Signal DetectionSafety EvaluationRisk ManagementSafety SurveillanceData VisualizationClinical ExperiencePharmacovigilanceSafety System DatabaseSOP DevelopmentExcel Pivot Tables
Soft Skills
Effective CommunicationTime ManagementPrioritization
Certifications & Qualifications
Master DegreePharmDPhD
Industry Keywords
Pharmaceutical IndustryBiotech IndustryHealth AuthorityClinical TrialsPost-Marketing
About the role
Key responsibilities & impact- Complete signal detection activities in line with approved safety surveillance plans
- Perform signal evaluations and author safety evaluation reports
- Manage preparation and review of safety documents, including DSUR, PSUR and RMP
- Respond to health authority and other queries
- Prepare and deliver presentations at Signal Management Team meetings
- Participate in clinical study team meetings for assigned compounds
- Participate in risk management activities for assigned compounds
- Represent Global Patient Safety on cross-functional teams, including RSOC and IDMCs
- Manipulate and visualize safety data using Excel and pivot tables
- Participate in process improvement initiatives, including development and maintenance of SOPs, work instructions and supporting documents
Requirements
What you’ll need- Minimum Master degree, PharmD, PhD
- Previous safety or relevant clinical experience in the pharmaceutical industry required
- Typically at least 5+ years of risk management or relevant clinical experience in the pharmaceutical/biotech industry or health authority
- Clinical experience and/or industry experience in the therapeutic area of interest is a plus
- Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities in clinical trial and post-marketing environments
- Ability to work with a safety system database for medical case review and simple queries
- Advanced understanding of safety surveillance activities and principles
- Ability to meet deliverables, effectively use time and prioritize
- Ability to effectively communicate safety findings verbally and in writing
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation for applicants with known disabilities or chronic illnesses, where required