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Brigham Howard
Pharmacovigilance Safety Expert
Summary
A highly skilled and experienced Pharmacovigilance Safety Expert with over 15 years of experience in the pharmaceutical industry. Proven ability to develop and implement effective pharmacovigilance risk management strategies, establish and maintain robust pharmacovigilance systems, and lead cross-functional teams in the investigation and evaluation of adverse events. Excellent communication and interpersonal skills with a strong understanding of regulatory requirements and guidelines.
Education
Doctor of Pharmacy (Pharm.D)
January 2015
Skills
- Pharmacovigilance Signal Detection
- Drug Safety Case Management
- Regulatory Reporting and Compliance
- Medical Literature Evaluation
- Pharmacoepidemiology
- Data Management and Analysis
Work Experience
Pharmacovigilance Safety Expert
- Developed and implemented training programs for healthcare professionals on pharmacovigilance best practices, ensuring early detection and reporting of adverse events.
- Collaborated with regulatory agencies worldwide to navigate complex regulatory requirements and secure marketing approvals for new therapies.
- Provided expert testimony on pharmacovigilance safety matters to regulatory and scientific bodies.
- Performed comprehensive literature reviews and conducted metaanalyses to evaluate the safety and efficacy of new and existing drugs.
Pharmacovigilance Safety Expert
- Developed and implemented pharmacovigilance risk management strategies for over 15 new drug applications, resulting in expedited approvals and reduced postmarket safety concerns.
- Established and maintained robust pharmacovigilance systems for global clinical trials, ensuring compliance with regulatory guidelines and protecting patient safety.
- Led crossfunctional teams in the investigation and evaluation of adverse events, identifying signal detection, managing risk assessments, and developing mitigation plans.
- Proactively monitored and analyzed safety data from multiple sources, including clinical trials, postmarketing surveillance, and spontaneous reporting systems, to identify potential safety risks.
Accomplishments
- Established a comprehensive system for monitoring and reporting adverse drug events, resulting in a 20% increase in detection rate.
- Developed and implemented a risk management plan for a highrisk drug, mitigating potential risks to patients.
- Collaborated with healthcare professionals to develop educational materials on drug safety, reaching over 5,000 healthcare workers.
- Led a team in conducting a literature review to identify emerging drug safety concerns, resulting in the publication of a peerreviewed article.
- Implemented a system for expedited reporting of serious adverse events, reducing reporting time by 50%.
Awards
- Received the Pharmacovigilance Safety Excellence Award for outstanding contributions to drug safety surveillance.
- Recognized for exceptional performance in conducting postmarketing safety studies.
- Presented with the Industry Leader Award for contributions to the advancement of pharmacovigilance practices.
- Recognized for outstanding achievement in the field of pharmacovigilance by the International Society of Pharmacovigilance.
Certificates
- Certified Safety Professional (CSP)
- Registered Pharmacovigilance Professional (RPP)
- Certified Clinical Research Professional (CCRP)
- Postgraduate Diploma in Clinical Research and Drug Development
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How To Write Resume For Pharmacovigilance Safety Expert
- Quantify your accomplishments with specific metrics and results.
- Highlight your expertise in pharmacovigilance signal detection, drug safety case management, and regulatory reporting and compliance.
- Demonstrate your ability to work effectively in a team environment and manage multiple projects.
- Showcase your understanding of the latest pharmacovigilance trends and best practices.
- Consider obtaining certifications such as the Certified Pharmacologist (CPh) or the Certified Safety Professional (CSP) to enhance your credibility.
Essential Experience Highlights for a Strong Pharmacovigilance Safety Expert Resume
- Develop and implement pharmacovigilance risk management strategies for new drug applications to expedite approvals and reduce postmarket safety concerns.
- Establish and maintain robust pharmacovigilance systems for global clinical trials to ensure compliance with regulatory guidelines and protect patient safety.
- Lead cross-functional teams in the investigation and evaluation of adverse events, identifying signal detection, managing risk assessments, and developing mitigation plans.
- Proactively monitor and analyze safety data from multiple sources to identify potential safety risks.
- Develop and implement training programs for healthcare professionals on pharmacovigilance best practices to ensure early detection and reporting of adverse events.
Frequently Asked Questions (FAQ’s) For Pharmacovigilance Safety Expert
What is the role of a Pharmacovigilance Safety Expert?
A Pharmacovigilance Safety Expert is responsible for monitoring the safety of drugs and ensuring the effective management of adverse events and drug risks. They work closely with regulatory agencies, healthcare professionals, and patients to ensure the safety and efficacy of pharmaceutical products.
What are the key skills and qualifications for a Pharmacovigilance Safety Expert?
Key skills include: pharmacovigilance signal detection, drug safety case management, regulatory reporting and compliance, medical literature evaluation, pharmacoepidemiology, data management and analysis.
What are the career prospects for a Pharmacovigilance Safety Expert?
Career prospects are excellent for qualified Pharmacovigilance Safety Experts. The growing focus on patient safety and the increasing complexity of drug development have led to a high demand for these professionals.
What is the salary range for a Pharmacovigilance Safety Expert?
The salary range for a Pharmacovigilance Safety Expert can vary depending on experience, location, and company size. According to Salary.com, the average salary for a Pharmacovigilance Safety Expert in the United States is between $100,000 and $150,000 per year.
What are the top companies hiring for Pharmacovigilance Safety Experts?
Top companies hiring for Pharmacovigilance Safety Experts include Pfizer, Genentech, Novartis, Roche, and Merck.
What are the key trends in pharmacovigilance?
Key trends in pharmacovigilance include the use of big data and artificial intelligence to enhance signal detection and risk assessment, the increasing focus on patient-centric approaches, and the growing importance of global collaboration.