Senior Pharmacovigilance Specialist, Case Processing - 12 Month Fixed Term (FTC)

Company profile

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 opportunity

The Senior Pharmacovigilance Specialist, Case Processing is tasked with managing pharmacovigilance cases through call intake, documentation and case processing. This will entail performing the initial assessment of seriousness, expectedness, causality and reportability of adverse events. In addition you will also write accurate and complete narratives, report cases in accordance with internal guidelines, SOPs and Global safety regulations. The role will also require performing case quality check and signal detection activities and may act as client contact for case management and reporting functions. Ideally you will proactively maintain a distinctive quality and commitment approach as the operating philosophy in carrying out all processes and will continually seek out ways to enhance the customer service experience.

Essential Functions Include:

• Assist call intake staff with call management and documentation of pharma, and vaccine products as needed
• Conduct daily case processing of adverse event cases. Pharmacovigilance Case Processing
• Case and event assessment
• Identify events and code using MedDRA
• Determine seriousness and expectedness of each event.
• Determine overall case assessment of seriousness and expectedness.
• Perform assessment review, capture causality
• Case follow-up activities
• Identify information to be collected during follow-up
• Conduct follow-up calls and prepare written communications to obtain follow-up information
• MedWatch, CIOMS, E2B Preparation
• Conduct daily review of medical information cases
• Write case narratives and review MedWatch/CIOMS/E2B forms
• Provide signal detection analysis within aggregate reports Case QC Review
• Perform in-line case QC review including the following, but not limited to:
• Report Type/Reportability
• Event MedDRA coding
• Seriousness and expectedness at the event and case level
• Accuracy and completeness of the narrative
• Provide feedback for development of training material as needed Client Interaction
• Address client questions on case management and processes
• Complete client notifications as required for case management
• Develop training materials, conduct training presentations and on-the-job training for Call Center, Medical Information and Pharmacovigilance staff
• Other duties as assigned

Qualified candidates must have:

• RN, RPh, or PharmD, DVM or equivalent or life science degree Current healthcare license for degree or equivalent
• Must have 2-3 years’ experience working in Pharmacovigilance
• Demonstrated experience working in a Case processing role within a Consultancy or Service provider is highly desirable
• Proficient computer knowledge and computer keyboarding skills including intermediate proficiency with Microsoft Office Suite (Outlook, Word, Excel)
• Working knowledge and understanding of the legal, regulatory and pharmacovigilance environment within pharmaceutical industry
• Excellent internal and external customer service skills
• Strong verbal, written and interpersonal communication skills with clients and internal staff
• Excellent attention to detail
• Excellent organization, prioritization, project management and delegation skills; with strong attention to detail
• Able to work independently and collaboratively in a multidisciplinary team
• Able to occasionally work extended and/or flexible schedule to meet client requirements

Additional Information

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 call***