Drug Safety Case Management Lead

SUMMARY

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.

RESPONSIBILITIES

• Assist call intake staff with call management and documentation of pharma, and 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

QUALIFICATIONS

• RN, RPh, or PharmD, DVM or equivalent or life science degree
• 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

DURATION

9 month Fixed term contract

SALARY

Attractive hourly pay rate

LOCATION

Homebased anywhere in UK, Germany, Sweden, or Netherlands

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

Please click ‘apply’ or contact Sam Chapple (Recruitment Team Lead) at Planet Pharma for more information:

E: schapple@planet-pharma.co.uk

T: +44(0)203 868 8607

Linkedin: https://www.linkedin.com/in/sam-chapple-42b459131/