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Manager, Pharmacovigilance

5+ years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.