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Job Details

Senior Safety Scientist (London)

Company: United BioSource Corporation.
Location: Hammersmith
Reference: REQ9041
Closing Date: 30 Sep 18
Type: Full Time
Salary (£): Competitive
Benefits:

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Job Summary:

UBC is a fast growing company, patients and people focused on Clinical Development & Research and Safety & Risk Management. In order to continue our accelerated growth, we are seeking talented “Senior Safety Scientists” to define and execute this vision. If you are passionate about Pharmacovigilance and if you recognize yourself in the description below – join us!

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. 

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 a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety. While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management.

Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.

By combining insight from data, understanding patient behavior, and the science behind clinical specialties, we can help our clients make informed decisions and optimize the care given to patients using their therapies and products.

Keywords

Safety Scientists / Drug Safety Officer / Pharmacovigilance Associate / Pharmacovigilance Scientist / Post Market Coordinator / Pharmacovigilance Officer / Pharmacovigilance Expert / Vaccines Safety Officer / Physician / QPPV / Clinical Trials / QA / QC / Project Manager / Team Leader / Switzerland / France / UK / Germany / Spain / Portugal / Italy / Greece / Ireland / Poland / Bulgaria / Romania / Hungary / Belgium / Netherlands / Austria / CRO / Contract Research Organisation / Biology / Biotechnology / Pharmacy / Biochemistry / Chemistry / Pharmacology / Pharmaceutical Sciences / Molecular Biology / Bioinformatics / Life Sciences / Physiology / Biomedical Sciences

Apply for this job: Senior Safety Scientist (London)

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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