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Job Details

Senior Pharmacovigilance Associate

Company: United BioSource Corporation.
Location: Vernier, Geneva, Switzerland
Reference: REQ20007699
Closing Date: 17 Nov 17
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive Package

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Job Summary:

This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, individual case safety report (ICSR) case processing and reporting; global and local literature review; assisting with project start-up: process flows; assist with database configuration needs; support preparation and quality control of safety aggregate reports; training,...

Requirements:

Brief Description:

This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, individual case safety report (ICSR) case processing and reporting; global and local literature review; assisting with project start-up: process flows; assist with database configuration needs; support preparation and quality control of safety aggregate reports; training, mentoring and contributing to the development and maintenance of departmental standards (SOPs) and guidelines. 

Supervisory Responsibilities:

• Lead project teams

• Train and mentor personnel assigned to project teams

Specific Job Duties:

• Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required

• Review project specific proposals, pricing and protocols to ensure consistency within the AERP

• Maintain oversight of all administrative changes and updates

• Ensure compliance with project specific processes and SOPs

• Alert Project Management when activities fall outside SOW or documented processes

• Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment

• Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings

• Maintain oversight of case workflow; act as Workflow Manager for specific projects

• Actively engage in gap analysis for SOPs and guidance documents

• Preparation of training materials specific to safety, participate and/or lead training sessions

• Assist in the reconciliation of clinical and safety databases

• Contribute to the preparation and quality control of responses to authorities, company core data sheets, signal detection and assessment

• Perform literature review for identification of case reports and other relevant safety information

• Collaborate with Management to update or design project process improvements

• Liaise with both internal and external vendors (clients, patients and HCPs)

• Review/Quality Check (QC) of source documents, coding, data entry, report generation and distribution

• Monitor compliance metrics and ensure appropriate documentation when deficient.

• Assist in evaluation and validation of systems to support safety

Requirements:

• Registered Nurse, Pharmacist, or other degree in a Life Science-related field

• Knowledge of ICH, EMA and FDA Regulations and Guidelines both clinical and post marketing pharmacovigilance and clinical safety

• Prior experience in CRO/Pharma/Biotech safety department, minimum 3 years

• Knowledge of vaccine and medical device reporting requirements, a plus

• Proficient with case review, extrapolation and composition of ICSR narratives and causality assessment

• Proficient with computer programs (Safety database, Word, PowerPoint, Excel)

• Good communication, interpersonal interaction, project management and organizational skills are essential

• Fluent in English, additional language fluency a plus, but not required

ABOUT UBC

United BioSource Corporation (UBC) is the leading provider of integrated pharmaceutical support services that optimize global product safety, brand loyalty and patient access on behalf of our manufacturer clients.

 

UBC’s services include Clinical Development & Late Stage Research, Risk Management & Pharmacovigilance, Reimbursement & Patient Assistance, Nursing & Adherence and Product Access & Channel Management.  UBC works hand-in-hand with Accredo and CuraScript SD to contract with manufacturers for specialty pharmacy and distribution services.

 

ABOUT EXPRESS SCRIPTS

Advance your career with the company that makes it easier for people to choose better health. Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes. Join the company that Fortune magazine ranked as one of the "Most Admired Companies" in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services. We offer a highly competitive base salary and a comprehensive benefits program, including medical, prescription drug, dental, vision, 401(k) with company match, life insurance, paid time off, tuition assistance and an employee stock purchase plan.

 

Express Scripts is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, national origin, age, veteran status, disability, or any other protected class. Applicants must be able to pass a drug test and background investigation. Express Scripts is a VEVRAA Federal Contractor.

*LI-CD1-UBC

Apply for this job: Senior Pharmacovigilance Associate

Contact Information:

Address:  United BioSource Corporation (UBC)
Europe Headquarters
26-28 Hammersmith Grove
London
United Kingdom
W6 7HA
England
Tel:  +44 (0)20 8834 0100
Website:  Visit Our Web Site

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