FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in signal detection and evaluation, including preparation of safety documents and presentations. Strong understanding of pharmacovigilance regulations and risk management in clinical and post-marketing environments.
Highest-signal resume keywords
Signal Detection ActivitiesSafety Evaluation ReportsRisk Management ExperiencePharmacovigilance RegulationsSafety System Database
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 EvaluationSafety Document PreparationSafety Data AggregationBenefit-Risk AssessmentClinical Trial Regulations
Soft Skills
Effective CommunicationTime ManagementPrioritization
Tools & Technologies
Safety System Database
Certifications & Qualifications
Master's DegreePhDPharmD
Industry Keywords
Pharmaceutical IndustryBiotech IndustryFDA GuidelinesEU RegulationsICH Guidelines
About the role
Key responsibilities & impact- Complete signal detection activities in line with approved safety surveillance plan
- Perform signal evaluation for identified signals and author safety evaluation reports
- Manage preparation and review of safety documents including DSUR, PSUR, RMP, and responses to health authority or 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, IDMCs and teams with external members
- Participate in process improvement initiatives, including development and maintenance of SOPs, WIs and supporting documents
- Support safety strategies for molecules in clinical development and post-marketing phases through safety data aggregation, review, analysis, safety interpretation and benefit-risk assessment
Requirements
What you’ll need- Minimum a Master's, PhD, or PharmD
- 7+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority
- Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
- Ability to work with a safety system database for purposes of medical case review and simple queries
- Ability to meet deliverables and effectively use time and prioritize
- Ability to effectively communicate verbal and written safety findings
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 during the recruitment process where required