PV Scientist

• Report to a Senior PV Scientist as part of the Pharmacovigilance team
• Prepare and author aggregate safety reports for assigned products, including PSURs, DSURs, and Risk Management Plans
• Facilitate signal management processes, including signal tracking and safety data evaluations for new signals
• Conduct safety literature reviews and obtain necessary data from other groups
• Work with Clinical Trial physicians and Global Safety Officers on investigational programs, including protocol review and data analysis
• Coordinate and author responses to safety questions from regulatory authorities
• Contribute to process improvement initiatives involving aggregate reporting and signal management
• Serve as a Subject Matter Expert for global safety regulations and data analysis
• Collaborate with clinical trial safety teams and ensure compliance with global safety regulations

Requirements

• Bachelor's Degree in biologic or natural science or health care discipline
• Significant experience within Pharmacovigilance in the Pharmaceutical or Biotechnology industry, with experience of pharmacovigilance signal detection (signalling), OR significant experience within the medical device / medtech industry, with experience in medical device post market surveillance (PMS)
• Proficiency in scientific and medical data interpretation and presentation
• Strong collaborative skills within team environments and with external colleagues
• Ability to lead substantive projects independently and collaboratively
• Familiarity with Pharmacovigilance and drug development regulations
• Strong organizational skills and ability to prioritize tasks independently
• Basic knowledge of common data processing software (Excel, PowerPoint, Microsoft Word, Business Objects)
• Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred
• Experience with safety database systems preferred

Core Competencies

Demonstrates expertise in Pharmacovigilance, including aggregate safety reporting, signal management, and compliance with global safety regulations. Proficient in scientific data interpretation and collaboration with clinical teams to enhance safety processes.

Highest-signal resume keywords

• Pharmacovigilance Experience
• Aggregate Safety Reporting
• Signal Detection
• Data Analysis
• Regulatory Compliance

ATS Optimization Keywords Hard Skills

• Safety Data Evaluation
• Literature Review
• Data Interpretation
• Project Leadership
• Signal Management

Soft Skills

• Collaborative Skills
• Organizational Skills
• Independent Prioritization

Certifications & Qualifications

• Bachelor's Degree in Biologic Science
• Advanced Degree (PhD, MPH, NP, PharmD)

Industry Keywords

• Pharmaceutical Industry
• Biotechnology Industry
• Medical Device Industry
• Post Market Surveillance
• Global Safety Regulations

Tools & Technologies

• Excel
• PowerPoint
• Microsoft Word
• Business Objects
• Safety Database Systems