CV / English / Drug Safety Manager
234 Pharma Lane, Drugville, DX 78901 Phone: (555) 123-4567 Email: [email protected]
A diligent and experienced Drug Safety Manager with over 8 years of experience in pharmacovigilance, adept at managing drug safety processes, and ensuring compliance with global regulatory requirements. Proven track record in leading cross-functional teams to achieve project deadlines and objectives while maintaining the highest standards of drug safety practices.
Core Competencies
- Regulatory Compliance
- Pharmacovigilance Systems
- Risk Management
- Adverse Event Reporting
- Data Analysis & Trend Identification
- Team Leadership & Training
- Strategic Planning & Implementation
- Cross-Functional Collaboration
Technologies and Certifications
- Proficient in Argus Safety Database
- Skilled in MedDRA and WHO Drug Dictionaries
- Certified in Good Pharmacovigilance Practices (GPVP)
- Project Management Professional (PMP) Certification
Professional Experience
Global Pharma Corp – Drug Safety Manager
Drugville, DX | Jan 2017 – Present - Led the drug safety team in processing and reporting adverse event cases to regulatory agencies, achieving a 99% compliance rate. - Implemented a new pharmacovigilance software system that improved adverse event report processing times by 20%. - Coordinated with R&D and clinical teams to identify safety signals and devise risk management strategies.
Health Solutions Ltd. – Pharmacovigilance Associate
MedCity, MC | Jun 2013 – Dec 2016 - Managed and reported over 5000 individual case safety reports ensuring accurate and timely submission. - Supported the development of safety monitoring plans for clinical trials. - Assisted in the preparation of periodic safety update reports and other regulatory documents.
Education and Training
Master of Science in Pharmacology University of Health Sciences, Drugville, DX | 2011 – 2013
Bachelor of Science in Pharmacy Pharma College, MedCity, MC | 2007 – 2011
Ongoing professional development in drug safety regulations, risk management, and pharmacovigilance software applications.
Referees
Available upon request.