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Detailed Description

The Manager, Clinical Case Processing manages Pharmacovigilance (PV) staff and provides oversight to PV activities, workflow, processes, and procedures. The Manager, Clinical Case Processing provides oversight for serious adverse event case intake and case processing, ensuring PV activities are processed consistent with internal guidelines, SOP, and global safety regulations. The Manager, Clinical Case Processing collaborates with other PV management to coordinate, develop, and maintain all aspects of ProPharma Group’s PV services. The Manager, Clinical Case Processing acts as an oversight manager for PV clients, continually seeking out ways to enhance customer service experience, both internally and externally.

Staff Management:

• Provides oversight and direction to PV Specialist staff.
• Demonstrates leadership, coaches, mentors, motivates, develops, and guides staff.
• Makes decisions consistent with company guidelines and policies.
• Fosters teamwork and collaboration; resolves conflict.
• Monitors and provides staff with ongoing performance feedback and conducts annual performance and compensation reviews, along with promotional recommendations.
• Participates in staffing responsibilities: hiring, training, and separations.
• Communicates the needs of the department and provides solutions.
• Ensures training and development plans are in place for all direct reports.
• Performs induction and onboarding of direct reports.
• Conducts timesheet reviews, approvals, and analysis, along with holiday/PTO/ad hoc flexible working approvals.
• Other duties as assigned.

Clinical PV Operations:

• Conducts case review for training feedback.
• Oversees case management and provides guidance and assistance to staff, including daily case processing support.
• Ensures case processing meets SOP requirements.
• Reviews (S)AE/SUSAR reports for regulatory authority compliance.
• Maintains and develops departmental controlled processes, including SOPs, conventions, work instructions, job aides, and training materials.
• Addresses client questions on case management and processes.
• Acts as an oversight manager for PV clients.
• Develops and updates training documents and training curriculum.
• Identifies training needs, conducts training, and provides on-the-job training for assigned PV staff.
• Ensures assigned PV staff are trained for assigned duties.
• Supports client implementations and onboarding, including attending client meetings to explain processes, review Safety Management Plans (SMPs), documents, and creation of client processing guidelines.

Acts as local representative for PV, as applicable.

• Flexible leadership style and team building skills.
• Proficient computer knowledge and computer keyboarding skills with familiarity of Microsoft Office Suite (Outlook, Word, Excel).
• Working knowledge and understanding of the legal and regulatory environment within pharmaceutical industry.
• Excellent    organization,     prioritization,     project    management    and delegation skills; with strong attention to detail.
• Self-motivated to maintain high efficiency and productivity levels and manage multiple projects and clients.
• Strong verbal, written and interpersonal communication skills.
• Excellent internal and external customer service skills.
• Able to work independently and collaboratively in a multidisciplinary team.

Able to occasionally work extended and/or flexible schedule to meet client requirements.

• Life science degree (Bachelor’s required. Advanced degree preferred), RN, RPh, PharmD or equivalent.

Current license for degree or equivalent from another state or country, as applicable.

• Required: Knowledge of clinical trials, drug development and Global pharmacovigilance regulatory reporting requirements.
• Required: 2 years of working in an acute care setting, community pharmacy or pharmaceutical industry.
• Preferred: 2 years of management experience including supervision of others.
• Preferred: Knowledge of relevant clinical trial and pre-market safety regulations and guidelines.
• Preferred: Experience interacting with partner or client companies
• Preferred: Experience with pharmaceutical safety database.
• Preferred: Strong analytical skills.

Preferred: Project management experience.