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.
Demonstrates extensive expertise in signal detection and evaluation, risk management, and safety document preparation 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 ActivitiesRisk Management ExperienceSafety Evaluation ReportsPharmacovigilance GuidelinesSafety 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 AssessmentsClinical ExperienceProcess Improvement InitiativesSOP DevelopmentMedical Case ReviewSafety InterpretationHealth Authority Queries
Soft Skills
Effective CommunicationProactive ApproachSelf-DisciplineTime ManagementPrioritization
Certifications & Qualifications
Master's DegreePhDPharmD
Industry Keywords
Pharmaceutical IndustryBiotech IndustryClinical DevelopmentPost-Marketing SafetyRisk ManagementSafety Surveillance PlansCross-Functional TeamsClinical Study TeamsTA of InterestRegulatory Compliance
About the role
Key responsibilities & impact- Complete signal detection activities in line with approved safety surveillance plans
- Perform signal evaluation for identified signals and author safety evaluation reports
- Manage preparation and review of safety documents including DSUR, PSUR and RMP
- Prepare responses 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, IDMC and teams with external members
- Serve as a resource for medical review of assigned compounds
- 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 and analysis
- Support safety interpretation and benefit-risk assessments
Requirements
What you’ll need- Minimum a Master's, PhD, or PharmD (Terminal Degree preferred)
- 9+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
- Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 8-10+ years of risk management or relevant clinical experience in 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 be proactive and self-disciplined, meet deliverables, effectively use time and prioritize
- Ability to effectively communicate verbal and written safety findings
- Clinical experience and/or industry experience in the TA of interest is a plus
- 25% travel may be required
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