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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance activities, including adverse event reporting, safety data administration, and regulatory compliance. Proficient in managing safety databases and drafting safety update reports while ensuring adherence to quality standards and regulatory timelines.
Highest-signal resume keywords
Pharmacovigilance ExperienceAdverse Event ReportingSafety Database ManagementRegulatory ComplianceMedical Coding
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
PharmacovigilanceAdverse Event Case ProcessingData AnalysisSignal DetectionSafety Profile EvaluationSOP DevelopmentRegulatory ReportingScientific Literature ReviewTraining Documentation ManagementCase Reconciliation
Soft Skills
Excellent Communication SkillsOrganized Work HabitsGood Planning SkillsConsensus BuildingInterpersonal Skills
Tools & Technologies
Integrated Safety DatabaseSafety Databases
Industry Keywords
Pharmaceutical ProductsClinical ResearchCROEU Pharmacovigilance PracticesUS Pharmacovigilance PracticesRegulatory AffairsCAPA ManagementPeriodic Safety Update ReportsPharmacovigilance ContractsHealth Sciences
About the role
Key responsibilities & impact- Provide operational support for global pharmacovigilance activities involving Grifols marketed products
- Ensure pharmacovigilance deliverables meet quality standards and global regulatory reporting timelines
- Review, compile, analyze, and manage data in the integrated safety database
- Process adverse event case reports and conduct follow-up
- Notify regulatory agencies and business partners and respond to regulatory requests
- Review scientific literature and bibliographic sources
- Draft and manage periodic safety update reports
- Evaluate safety profiles and draft and manage signal detection reports
- Ensure document filing and archiving
- Collect, process, review, and distribute adverse event information for development and marketed pharmaceutical products
- Conduct case reconciliation with departments, affiliates, distributors, and business partners
- Participate in self-inspection visits, audits, inspections, and CAPA management
- Create or update pharmacovigilance procedures, working practices, SOPs, and procedural documentation
- Provide training and manage training documentation
- Review product monographs and draft responses to regulatory agencies
- Participate in drafting and implementing pharmacovigilance contracts and agreements
- Assist management with ad hoc requests
Requirements
What you’ll need- Bachelor’s Degree in Health sciences (pharmacy, nursing, medicine, veterinary) or Bioscience (biochemistry, biotechnology, biology)
- At least one year of relevant experience in pharmacovigilance, clinical research, or regulatory affairs in a CRO or a pharmaceutical company
- 2-3 years of experience with pharmacovigilance and adverse event reporting is highly preferred
- Knowledge of EU and US pharmacovigilance practices; existing legislation, regulations and guidelines
- Expertise in therapeutic products and areas; medical coding; safety-data administration
- System knowledge of safety databases is required
- Excellent communication skills with different internal and external stakeholders
- Scientific expertise, organized work habits, and good planning skills
- Ability to work with diverse groups to obtain consensus on issues
- Ability to communicate and understand information presented through spoken and written words
- Ability to lift and carry objects up to 25 lbs
- Frequently drive to site locations with occasional travel within the United States
Benefits
Comp & perks- Up to 5% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
- Opportunities for professional growth and career progression