Pharmacovigilance Manager, Case Processing

🔥 27 minutes ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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ProPharma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 2001

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 $8.6M Venture Round on 2020-10

Healthcare • Logistics • Manufacturing

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• Supervise PV staff and provide oversight of pharmacovigilance activities, processes and procedures • Oversee adverse event intake and case processing • Ensure PV activities are processed consistently with internal guidelines, SOPs and global safety regulations • Collaborate with PV management to coordinate, develop and maintain ProPharma's pharmacovigilance services • Act as client contact for case management communications • Participate in process, workflow and supporting-document development and continuous improvement • Provide oversight and direction as a PV subject matter expert • Supervise workload, provide performance feedback and conduct annual reviews • Lead, coach, mentor and motivate staff • Handle hiring, scheduling and training responsibilities • Foster teamwork, resolve conflicts and communicate departmental needs to management • Review cases for training feedback and ensure regulatory compliance • Maintain and update work instructions, training materials and templates • Identify and address PV staff training needs • Support client implementation through meetings, guideline creation and process explanation • Perform billable case processing, quality-control case review, inbox assistance or other case-processing activities

🎯 Requirements

• Bachelor's degree in life sciences or an equivalent combination of relevant education and work experience • Five years of related work experience • One year of leadership experience • Strong verbal, written and interpersonal communication skills with clients, external and internal staff • Excellent project management skills • High level of accuracy and attention to detail • Excellent problem-solving skills and ability to resolve problems in a timely manner • Ability to work independently and collaboratively in a multi-disciplinary team • Excellent organization and prioritization skills with attention to detail • Advanced knowledge of Pharmacovigilance • Advanced knowledge of PV systems, such as Oracle Argus Safety, ARISg, or other safety databases • Self-motivated to maintain high efficiency and productivity levels and manage multiple projects and clients • Preferred: an advanced degree, RN, RPh, PharmD or equivalent • Preferred: one year of people management experience

🏖️ Benefits

• Remote working support • Hybrid working option for new hires based within a reasonably short commute of an office, as agreed with the manager • Equal Opportunity Employer workplace committed to diversity, equity, and inclusion

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