Pharmacovigilance Manager, Case Processing

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Manage the pharmacovigilance (PV) team and oversee all pharmacovigilance activities, processes, and procedures.

• Supervise the intake of adverse events and the processing of cases.

• Ensure that PV activities align with internal guidelines, standard operating procedures (SOPs), and global safety regulations.

• Work collaboratively with PV management to develop, coordinate, and maintain ProPharma's pharmacovigilance services.

• Serve as the primary client contact for communications related to case management.

• Engage in the development of processes, workflows, and supporting documents, while driving continuous improvement.

• Provide oversight and guidance as a subject matter expert in pharmacovigilance.

• Manage workloads, offer performance feedback, and conduct annual reviews for the team.

• Lead, coach, mentor, and inspire staff members.

• Manage hiring, scheduling, and training duties.

• Promote teamwork, mediate conflicts, and communicate departmental requirements to management.

• Review cases to provide training feedback and ensure compliance with regulatory standards.

• Maintain and revise work instructions, training materials, and templates.

• Identify and address training needs for PV staff.

• Support client implementation through meetings, guideline development, and process explanations.

• Conduct billable case processing, quality control case reviews, inbox assistance, or other case-processing tasks.

⛳️ Requirements

• A Bachelor's degree in life sciences or a comparable combination of relevant education and work experience.

• A minimum of five years of related work experience.

• At least one year of leadership experience.

• Strong verbal, written, and interpersonal communication skills with clients and both external and internal staff.

• Exceptional project management abilities.

• High level of accuracy and meticulous attention to detail.

• Excellent problem-solving skills with an ability to resolve issues promptly.

• Capacity to work both independently and collaboratively within a multidisciplinary team.

• Outstanding organizational and prioritization skills with a keen attention to detail.

• Advanced understanding of pharmacovigilance principles.

• Proficient knowledge of PV systems, including Oracle Argus Safety, ARISg, or other safety databases.

• Self-motivated to uphold high efficiency and productivity levels while managing multiple projects and client relationships.

• Preferred: an advanced degree, RN, RPh, PharmD, or equivalent qualifications.

• Preferred: one year of experience in people management.

🏝️ Benefits

• Support for remote work arrangements.

• Hybrid work option for new hires located within a reasonable commuting distance from an office, as agreed upon with the manager.

• A workplace that is an Equal Opportunity Employer, dedicated to promoting diversity, equity, and inclusion.