- Serve as a product lead for Pharmacovigilance activities
- Oversee and lead safety signal management processes and aggregate reports
- Respond to safety inquiries from internal and external stakeholders
- Review medical and scientific literature for safety information
- Support Clinical Trial PV medical activities
- Collaborate with leadership to hire, train, mentor, and manage staff focused on specific products
- Guide Safety and cross-functional teams on global safety regulations, data analyses, and product-specific information
- Conduct ongoing safety data reviews and signal detection activities
- Lead signal management activities, including detection, tracking, documentation, evaluation, authoring signal evaluation reports, and leading Safety Signaling Team meetings
- Manage literature review activities
- Oversee strategy, review, and finalization of PSURs, DSURs, RMPs, and related safety documents
- Prepare scientifically robust responses to regulatory authorities
- Collaborate with Global Safety Officers and Safety MDs on investigational programmes, clinical trial activities, and safety committee management
- Manage ad hoc safety data analyses and information requests
Requirements
- Advanced degree (PhD, MPH, NP, PharmD, etc.) required
- Significant years of pharmacovigilance experience, including aggregate safety reports and safety signal management
- Proficiency in interpreting, analyzing, and presenting scientific and medical data
- Strong foundation in pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations
- Basic knowledge of Excel, PowerPoint, Microsoft Word, Business Objects, and safety database systems
- Demonstrated leadership and collaborative skills within team environments
- Expertise in global safety regulations and guidelines preferred
- Experience in mentoring and managing staff within pharmacovigilance settings preferred
- Ability to apply clinical judgment in safety data interpretation preferred
Core Competencies
Demonstrates expertise in Pharmacovigilance activities, including safety signal management, regulatory compliance, and data analysis. Proven ability to lead teams, mentor staff, and collaborate effectively with cross-functional stakeholders in the pharmaceutical industry.
Highest-signal resume keywords
- Pharmacovigilance Experience
- Safety Signal Management
- Aggregate Safety Reports
- Global Safety Regulations
- Leadership and Team Management
Hard Skills
- Data Analysis
- Signal Detection
- Literature Review
- Safety Data Interpretation
- Clinical Trial Regulations
Soft Skills
- Collaborative Skills
- Mentoring
- Leadership
Certifications & Qualifications
- PhD
- MPH
- NP
- PharmD
Industry Keywords
- Pharmacovigilance
- Safety Signal Management
- PSURs
- DSURs
- RMPs
Tools & Technologies
- Excel
- PowerPoint
- Microsoft Word
- Business Objects
- Safety Database Systems
Senior PV Scientist in Maidenhead employer: Jobtailor
As a Client Services Coordinator at our dynamic company, you will thrive in a supportive work culture that prioritises employee growth and development. We offer comprehensive training, opportunities for advancement, and a collaborative environment where your contributions are valued. Located in a vibrant area, our team enjoys a healthy work-life balance and the chance to engage with diverse clients, making every day rewarding and meaningful.
