Senior Pharmacovigilance Manager, Case Processing

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Senior Pharmacovigilance (PV) Manager, Case Processing manages PV staff and provides oversight to PV activities, workflow, processes, and procedures. The Senior PV Manager, Case Processing is also responsible for clinical PV (CPV) and post-marketing PV service delivery, including leading and directing activities of the PV department to ensure services are processed consistent with internal guidelines, SOPs, global safety regulations, client contracts, safety management plans (SMPs) and Working Practices (WP). The Senior PV Manager, Case Processing collaborates with other PV management to coordinate, develop, and maintain all aspects of ProPharma's PV services and acts as an oversight manager for PV clients, continually seeking out ways to enhance customer service experience, both internally and externally.

Key Duties

• Provide strategic oversight as a PV subject matter expert, enhancing client service internally and externally.
• Manage workload strategically, providing comprehensive performance feedback and conducting thorough annual reviews. Adjust resourcing proactively as needed.
• Demonstrate leadership, coach, mentor, and motivate staff for optimal performance.
• Execute decisions aligned with company policies, driving innovation and efficiency.
  
  

Lead staffing strategies, including recruitment, talent acquisition, and comprehensive training programs.

• Drive the development and enhancement of work instructions, training materials, and templates.
• Identify strategic training needs, designing comprehensive competency frameworks for staff excellence.
• Spearhead initiatives to optimize processes, refine SOPs, and streamline workflow.
• Act as a trusted advisor in client engagements, driving successful implementation and process explanations.
• Achieve and exceed target utilization metrics through expert case processing and quality control.
• Undertake additional responsibilities and projects as assigned to advance organizational objectives.
• Perform billable work to adhere to target utilization as set by line manager based on span of control. Billable activities may include processing cases, QC cases, assisting with the inbox, or other case processing activities.
• Other duties as assigned.
  
  

Education, Skills And 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.
• Able to work independently and collaboratively in a multi- disciplinary team.
• Excellent organization, prioritization, project management and delegation skills, with strong 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.
• A Bachelor's degree or higher.
• Seven years of related work experience.
• Two years of people management experience.
  
  

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***