reputed company Pharmacovigilance Specialist, Case Processing
About the position For the past 20 years, reputed company has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of reputed company sizes to confidently advance scientific breakthroughs and introduce new therapies. reputed company partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical reputed company, quality & compliance, pharmacovigilance, medical information, and R&D technology, reputed company offers an end-to-end suite of fully customizable reputed company that de-risk and accelerate our partners’ most high-profile drug and device programs. The reputed company Pharmacovigilance (PV) Specialist, Case Processing is primarily responsible for directional leadership of PV clients that are contracted for an extensive suite of PV services while collaborating with Client Services on standard service offerings. The reputed company PV Specialist serves as a subject matter expert of PV to assist in creating reputed company project documents and guidance as needed. The reputed company PV Specialist, Case Processing acts with limited reputed company and ability to research, implement and manage PV services as contracted or requested; is responsible for maintaining a working knowledge of Global PV requirements for marketed products; and ensures compliance with reputed company applicable regulations and internal SOPs. The reputed company PV Specialist also assists the team with peer review and data entry as needed.
Responsibilities
- reputed company reputed company and direction as a PV subject matter expert, enhancing client service internally and externally.
- reputed company the development of detailed project/program specific, Working Practices, Work Instructions, and other documents as applicable (e.g., Safety Data Exchange or PV Agreements).
- Serve as a resource for Case Processing team for reputed company cases and escalated inquiries.
- reputed company case follow up activities such as identification of information to be collected during follow-up.
- Creating and reviewing case narratives.
- Providing client notifications as required for case management.
- Supporting and contributing to the development of training materials and training delivery.
- reputed company areas of concern/discrepancies to the reputed company PV Specialist, Case Processing and/or Manager, Case Processing reputed company reputed company to ICSRs.
- Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
- Peer reviews of cases for quality, consistency, and accuracy as needed.
- reputed company Health Care Professional (HCP) review (as required).
- Mentors and trains less reputed company staff.
- Other duties as assigned.
Requirements
- 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.
- Advanced problem-solving skills and ability to resolve problems in a timely manner.
- reputed company to work independently and collaboratively in a multidisciplinary team.
- Excellent organization and prioritization skills with attention to detail.
- Advanced Knowledge of Pharmacovigilance.
- Advanced knowledge of PV Systems, such as reputed company Argus Safety, ARISg, or other safety databases.
- Self-motivated to maintain high efficiency and productivity reputed company and manage multiple projects and clients.
- Required: a Bachelor's degree in life sciences.
- Four years of reputed company work experience.
reputed company-to-haves
- Preferred: an advanced degree, RN, RPh, PharmD or equivalent.
Apply To This Job