Senior Pharmacovigilance Specialist-COVID Support (Work From Home)
- Martin Luther Kingplein 48, 6161 HB Geleen, Netherlands
- Employees can work remotely
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
This is a contract role on a project in support of a COVID-19 Project. Must have recent or current Pharmacovigilance experience.
Manage pharmacovigilance cases through call intake, documentation and case processing. Perform initial assessment of seriousness, expectedness, causality and reportability of adverse events, write accurate and complete narratives, report cases in accordance with internal guidelines, SOPs and Global safety regulations. Perform case quality check and signal detection activities. May act as client contact for case management and reporting functions. Maintain distinctive quality and commitment as the operating philosophy in carrying out all processes. Continually seek out ways to enhance customer service experience both internally and externally.
- 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
- 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
- Flexible leadership style and team building skills
- 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
- RN, RPh, or PharmD, DVM or equivalent or life science degree
- Current healthcare license for degree or equivalent from state or country
- Preferred: 3 years of experience in an acute healthcare or community pharmacy or pharmaceutical industry experience
- Required: Minimum 3 years Drug safety experience
- Required: Management experience
- Preferred: Experience working with safety databases
- Preferred: Call center experience
- All candidates must be legally eligible to work in the Netherlands
- We are an equal opportunity employer. M/F/D/V
- ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***