Job Title: Manager, Pharmacovigilance
Location: Remote (UK/EU)
Company: Worldwide Clinical Trials - USA
Work Model: Remote / Home-based
Job Type: Full-time
Salary: Competitive
Start Date: 10 April 2025
Application Deadline: 10 May 2025
About the Company:
Worldwide Clinical Trials is a global, midsize Contract Research Organization (CRO) with 3,500+ professionals working across the drug development lifecycle. The company specializes in innovative and quality-driven clinical research for some of the world’s most persistent diseases. Their mission is to improve lives through passion, purpose, and pioneering work in clinical trials.
Department: Pharmacovigilance (PV)
The PV team ensures drug safety by reviewing, analyzing, and reporting safety events globally, playing a key role from first-in-human trials to global regulatory approval.
Key Responsibilities:
Team and Project Leadership:
Provide direct supervision of assigned staff and projects.
Guide, coach, and escalate study/staff-related concerns as necessary.
Participate in recruitment, onboarding, and training of team members.
Organize training sessions and staff development programs.
Regulatory and Process Compliance:
Ensure all PV activities comply with applicable regulations and internal SOPs.
Maintain updated knowledge of safety regulations and reporting requirements.
Represent PV in sponsor audits and client meetings as needed.
Operational Management:
Monitor project budget and scope, escalating issues when needed.
Participate in proposal reviews, bid defenses, and SOP authoring.
Handle multiple priorities and maintain tight project timelines.
Qualifications:
Education:
Bachelor’s degree in a science-related field, nursing, or equivalent.
Experience:
Minimum 5 years of experience in pharmacovigilance, especially pre-approval clinical trials.
Demonstrated leadership in guiding and supervising PV staff.
Experience working across functions in a global clinical environment.
Skills and Competencies:
Deep understanding of pharmacovigilance principles, adverse drug event assessment, and international safety regulations.
Strong proficiency in database management and data extraction.
Excellent verbal/written communication and organizational skills.
Ability to manage complex projects and prioritize tasks efficiently.
Comfortable with internal/external client interactions.
Willingness to travel domestically and internationally as needed.
Work Culture & Diversity:
Inclusive and collaborative environment fostering innovation.
Equal opportunity employer committed to diversity in hiring.
Employees are encouraged to be authentic and thrive as individuals.
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