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Job Details

Senior Pharmacovigilance Scientist

Company: Quanticate
Reference: ATR488
Closing Date: 05 Feb 17
Type: Full Time
Salary (£): Competitive

Job Summary:

This is a fantastic opportunity to further your career working in Pharmacovigilance, in a world-leading CRO that specialises in data-related services. You will have the opportunity to work as part of global project teams, gaining exposure to multiple high profile, global studies for major pharmaceutical clients, and providing valued input to the Pharmacovigilance function at Quanticate.


In order to be considered for this role, you will demonstrate the following key skills and attributes:

• Pharmacy, life science or healthcare degree
• Extensive hands on experience in all aspects of pharmacovigilance operations, both clinical trial and post-marketing, gained within the pharmaceutical, CRO or regulatory sector to include case entry, narrative writing, coding, assessment, case follow-up, reporting, line listing generation, signal detection, periodic report writing and literature review
• Experienced in PV reporting (expedited and periodic), including the use of EudraVigilance for electronic reporting
• Experience in managing PV projects and processes and preparing PV documentation such as Safety Plans
• Experience in case QC and mentoring of others
• Experience of Quality Management aspects of pharmacovigilance, including SOP development and participation on audits and inspections
• PV experience gained in a CRO, in a client-facing role
• Experience in business development for pharmacovigilance
• Experience as a safety database administrator
• Experience in medical device vigilanc
• Excellent communication skills, both written and verbal
• In depth knowledge of pharmacovigilance regulations and requirements
• Proficient in the use of industry standard safety databases, including proficiency in the use of Oracle Argus as an end user
• EudraVigilance trained and certified by the European Medicines Agency; proficient in the use of EudraVigilance and able to act as Responsible Person
• Good understanding of scientific and medical terminology
• Knowledgeable about global reporting requirements and able to continually update knowledge
• Proficient in the use of standard Microsoft Office software packages, such as Word, Excel and PowerPoint
• Strong attention to detail and the ability to perform accurate and complete QC
• Advanced organisational and time management skills; able to prioritise, plan and execute tasks efficiently and effectively, adhering to strict timelines and feeding back any potential issues in a timely manner

Your core responsibilities will be to:

• Manage the receipt and processing of cases (spontaneous, literature and clinical) in compliance with applicable regulations and Quanticate SOPs
• Triage of cases for completeness, accuracy and redaction, determining expectedness against the reference safety information and appropriateness for expedited reporting
• Prepare and submit customer notifications. Identify and send case follow-up requests. Prepare case narratives as appropriate. Ensure medical review of cases
• Entry of safety data onto the safety database(s) and tracking systems.  Quality checks data entered by colleagues.  Maintains a strong understanding of the Quanticate safety database conventions or client specific database conventions, as appropriate
• Submit expedited safety reports to applicable parties which may include regulatory agencies, ethics committees, investigators and other third parties.  All submissions must be tracked and submitted within regulatory and agreed timelines to ensure compliance
• Develop and maintain a co-operative working relationship with project team members.  Attend project team meetings, client meetings, and other meetings as appropriate for assigned projects.  Promptly advise the VP of PV of any significant safety and regulatory concerns including lack of compliance with expedited reporting
• Act as PV Operational Lead on assigned projects, providing oversight and ensuring that projects are set up and run according to all applicable regulations, guidelines, SOPs, quality standards and contracts, as well as to client requirements.  Provide PV operational advice to customers and be their primary point of contact for PV questions. Deputise and act as a PV back-up on other projects in the absence of the PV Lead
• Preparation and updating of project-specific Safety Plans, including defining local reporting requirements.  Writing or input into other project documents and processes such as the Data Management Plan, Coding Conventions and Literature Search Strategy
• Support Clinical Data Management in reconciliation tasks by providing listings from the safety database, reviewing for discrepancies and agreeing actions required
• Conduct regular reconciliation ensuring the terms of SDEAs are followed where appropriate and that any specific SDEA requirements are met
• Manage the preparation of files for archiving and transfer to customer at the end of projects
• Conduct literature reviews as required, reviewing abstracts and full articles to identify case reports and other safety issues
• Assist the PV Physician or Medical Monitor in signal detection activities, including organisation of Safety Review Meetings and provision of required data
• Assist in the preparation of aggregate reports such as PSURs and DSURs as required. Prepare monthly PV status reports for assigned customers
• Manage metrics for assigned projects ensuring tasks are completed efficiently and within the agreed budget. Conduct updates to project completion metrics at least weekly, ensure milestone payments are activated and assist Finance in provision of monthly invoice figures as appropriate
• Provide input into the development and update of processes including the development of SOPs and other procedural documentation
• Provide support for internal audits and regulatory inspections as appropriate.  Managing PV audit preparation for assigned customers
• Support the Safety Database Owner with configuration of client safety databases, liaising with IS support team on database updates, including MedDRA and WHO Drug dictionaries, user access updates, UAT scripts and support to the PV department with database related queries and requests
• Support junior team members through provision of safety database, Eudravigilance and XEVMPD training and general day to day pharmacovigilance support and advice
• Support the VP of PV in business development activities as required.  This may include budget preparation for customer RFPs, input into proposal documents, attendance at bid defence meetings and preparation of articles for conferences or the Quanticate website


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Contact Information:

Address:  Head Office
Bevan House Bancroft Court Hitchin, Hertfordshire United Kingdom
Tel:  +44 1462 440 084
Website:  Visit Our Web Site

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