Hendre has been with CK Clinical since 2007 and specialises in permanent and contract recruitment within Pharmacovigilance, Drug Safety and Medical Information.
For more information, contact Hendre directly:Tel. 01438 870 023 or email hmoolman@ckclinical.co.uk
A global pharmaceutical company is looking for a Drug Safety Associate to join their team based in Hertfordshire, UK. The company are looking for candidates who are enthusiastic, have ambition and want to progress in drug safety.
Qualifications and experience:
Qualified pharmacist, relevant nursing qualification, life sciences degree or experience in drug safety
Previous exposure to Drug Safety is an advantage
Knowledge of drug safety regulatory obligations
Good knowledge of medical terminology
Ability to write clear, concise, unambiguous medical text
Ability to acquire knowledge in different disease and therapeutic areas
Fluent in English
Able to evaluate data and draw conclusions independently
Computer literacy essential
Attributes:
Able to take ownership of assigned cases
Conveys a sense of urgency
Proven good communication skills with an international perspective
Able to work under pressure
Confident decision maker
Willing to travel if required
Good time management
Flexible,able to interact well within a team setting
Good attention to detail
Apply now
For more information or to apply for this Drug Safety Associate role, please contact Krishna at CK Clinical on 01438 743 047 or email kpankhania@ckclinical.co.uk. Please quote reference CL21685 in all correspondence.
We are recruiting for a Drug Safety Scientist to join a Pharmaceutical company in Buckinghamshire on a contract basis.
Background:
You will be responsible for coordinating the safety reporting and the collection, review and reporting of Adverse Events. Awareness of and familiarity with industry principles of drug development and pharmacology is required. A life science degree and/or equivalent proven experience in pharmaceutical regulations and R&D processes is required.
Key Responsibilities:
Safety Management and Reporting.
The coordination of safety reporting requirements as required for MAH and/or study sponsor, as applicable.
Collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Health Authorities (LHAs) and other potential sources.
Assist with initial quality review and assessment of individual cases.
Co-ordinate/perform the follow-up of missing information from the AE reporter.
Provision of local data supporting the preparation of Safety Summary reports (PSURs, and ASR).
Assist in the implementation of compliance standards and facilitate the collection of compliance metrics as required.
Ensure that day-to-day PV functions are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company (LOC) level.
Benefits:
Successful candidates will enjoy the benefits of working with a global Pharmaceutical company, including a COMPETITIVE RATE.
Qualifications and Experience:
Ability to negotiate and communicate with internal and external customers.
Biological sciences degree and/or equivalent proven expertise and experience in pharmaceutical regulations and R&D processes.
Apply Now
For more information or to apply for this Drug Safety Scientist position, please contact Hendre Moolman on 01438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL21610 in all correspondence.
Salary upwards of £75K plus car allowance, very good annual bonus
Working with the Head of Pharmacovigilance you will be responsible for the provision of a comprehensive Pharmacovigilance and Drug Safety service to European and Global; stakeholders.
Our client has a team of Drug Safety Medics. Whilst this role is not a management role within the department it is an ideal opportunity for a candidate with more experience to take on a leadership and mentoring position to other less experienced Pharmacovigilance medics and help them with their development.
Responsibilities:
As a Senior Medical Advisor, your key responsibilities will include:
To proactively manage the globalsafety aspects for a specific product, or group of products.
To be a member of the body that manages pharmacovigilance globally
To support the Head of Product Safetyand the Qualified Person for Pharmacovigilance (QPPV) in the collection, assessment, evaluation, distribution and reporting of individual and cumulative safety reports.
As the senior member of the team provide orientation, training and support, and to assist the Head of Product Safety in the maintenance of standards of performance
To lead the response to safety-related medical queries from regulatory authorities, external bodies and internally for specified products.
Be responsible for leading safety evaluation, including signal detection and benefit-risk analysis
This opportunity is a rare one to join an established and forward thinking safety department under the stewardship of one of the industries most respected and experienced heads.
Qualifications and Experience:
The key qualifications and qualities you will posses will be:
Experience as a Pharmacovigilance medic
GMC registration
A “can do” attitude with a genuine team focus
Outstanding communication skills
Tact, Diplomacy and an eye for detail
Apply Now
For a full job description or to discuss the role further, please contact Ben Traies on 01438 870021 or email btraies@ckmedics.com.
We are recruiting for an urgent three month Safety Manager contract role with a pharmaceutical company in Uxbridge, UK.
The successful candidate will report to the Director of Medical Information, Safety and Quality Assurance. The company is looking for an expert in pharmacovigilance regulations and reporting required to provide leadership and guidance to a team of UK safety advisors.
Key responsibilities:
Working as a Safety Manager, you will have the following roles and responsibilities:
Oversight of day to day reporting activities for spontaneous adverse events and product complaints
Management of on-going safety data exchanges and issue management as required.
Pharmacovigilance expertise is critical to the team,
To cover and provide leadership and guidance to the UK team
Over seeing expedited cases
Over seeing case processing
Handling day to day management responsibilities and networking with department
Line managing a team of 9
Expertise of MHRA and regulatory requirements
Apply Now
For more information, please contact Krishna at CK Clinical on 01438 743 047 or email kpankhania@ckclinical.co.uk.
Entitlement to work in the EEA is essential. Please quote reference CL21492 in all correspondence.
A Clinical Research Organisation based in the South of England is looking for a Regulatory and Drug Safety Administrator to join their team.
Responsibilities include:
Using software packages, such as Microsoft Word, Outlook, Powerpoint, Excel, Access, etc., to produce correspondence and documents, and maintain presentations, spread-sheets and databases.
Arranging meetings, preparing agendas, meeting minutes and notes.
Organising and storing paperwork, documents and computer-based information.
Managing and overseeing the dispatch of documents to Regulatory Authorities, Ethics Committees and other parties, as necessary.
General administrative duties including photocopying, printing, faxing.
Requirements & Experience:
A first degree would be desirable.
Previous administrative experience is required.
Previous experience of working in the pharmaceutical industry is also preferred.
Attention to detail is important.
Good interpersonal skills.
Experience in using Word processing, emailing and Internet facilities and willingness and aptitude to learn new technology applications.
Good organisational and planning skills including ability to work to tight deadlines.
Good communication skills including an ability to communicate clearly in writing.
Apply Now
For more information, or to apply for this Regulatory and Drug Safety Administrator position, please contact Krishna Pankhania at CK Clinical on +44 (0) 1438 743047 or kpankhania@ckclinical.co.uk. Quote Reference number: 20853.
A Drug Safety Manager is required to join an established pharmaceutical company based in Surrey, UK.
In this position you will work on the review, analysis, preparation and completion of reports of adverse drug experience to determine the safety profile of the company products. As Drug Safety Manager, you will need to manage resources in the safety team depending on local organisation and safety group size.
Key Responsibilities:
Further key responsibilities of this Drug Safety Manager position will include:
Organising and managing local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.
Managing, where applicable, safety resources in the local team.
Ensuring regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
Ensuring complete and timely submission of ICSR to the Core workflow.
Reviewing processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios.
Determining if appropriate case follow-up has been considered.
Consistently apply regulatory requirements and company policies.
Analysing and monitoring activities, defining and implementing corrective actions, where applicable.
Developing and maintaining expertise with advanced knowledge of all assigned products, of applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practises, of data entry conventions, and of search functions in the safety database.
Providing oversight and team monitoring on case handling aspects, data extraction, and analyses.
Leveraging and applying required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across all SRM DSU.
Acting as subject matter expert for SRM DSU within SRM.
Acting as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety data collection and handling.
Qualifications and Experience:
The ideal candidate for this Drug Safety Manager position will have the following qualifications and experience:
Ability to independently solve routine problems related to case processing and surface issues constructively.
Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact.
Experience in Pharmacovigilance required.
Solid working knowledge of pharmaceutical concepts.
Understanding and ability to use computer technology, management of relational database systems (specifically ARGUS), including extraction of data.
Strong skills in productivity, organisational and time management in order to meet strict regulatory compliance goals.
Excellent understanding of medical terminology.
Knowledge of global regulations and guidelines for drug development and post marketing activities.
Ability to work independently to accomplish team goals with minimal supervision.
Demonstrated ability to foster teamwork.
Experience of managing technical staff.
Apply Now
For more information or to apply for this Drug Safety Manager position, please contact Hendre on Tel: +44 (0)1438 870 023 or email me at hmoolman@ckclinical.co.uk quoting 20623 to indicate your interest.
Regulatory Affairs Manager required for biotechnology company based in Uxbridge, UK.
Our client, a pioneering biotechnology company, is currently looking for a Regulatory Affairs Manager to join their team based in Uxbridge, UK.
As a Regulatory Affairs Manager, you will be responsible for:
Using your knowledge of internal regulatory affairs to provide input into product strategy for the IE region.
Preparing internal market applications for new products.
Reviewing post market variations.
Liaise with CMC and help support the execution of labelling variations within the region.
Keep the IE project lead informed of all developments to do with the life cycle activity.
Provide advice and support on regional regulatory mechanisms to optimise product registration.
Contribute to product strategy.
Track status of MAA, variations, submissions and approvals.
Lead preparation of responses to questions raised by regulatory authorities.
The ideal candidate for this Regulatory Affairs Manager job will be educated to minimum Bachelors degree or will have equivalent education/experience. A Masters or Doctorial degree would be advantageous.
How to Apply
In order to register your interest in this Regulatory Affairs Manager job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.
Drug Safety Associate required for top pharmaceutical company based in Buckinghamshire, UK.
Our client, a top pharmaceutical company, are currently looking for a Drug Safety Associate to join their team based in Buckinghamshire. As a Drug Safety Associate, you will be responsible for the receipt and data entry of adverse event reports following Company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies. Previous case processing experience is required.
Further key responsibilities of this Drug Safety Associate role will include:
Triage of incoming cases to determine seriousness for prioritisation of daily workflow.
Confirmation of Safety Co-ordinator case registry data.
Database searches as necessary.
Completion of literature searches as necessary.
Completion of remaining case data entry, including narrative or auto-narrative.
Completion of risk and quality (label, approval, manual coding & quality review steps.
Clarification of unclear or illegible information from the LSO or Call Centre.
Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician.
Completion of protocol request forms as necessary.
Review and make suggestions for system and procedure enhancements.
Participation in inspections and audits, as required .
Participation in local or global project team.
This Drug Safety Associate position will focus on working on an oncology drug, therefore experience in oncology and the Argus database is a desirable. The ideal candidate for this position will also have a Life Science degree or be a qualified nurse. Pharmacists are not suited unless they have recent experience in Drug Safety.
The successful candidate will enjoy the benefits of working to a global pharmaceutical company, including a competitive rate.
If you would like more information regarding this Drug Safety Associate job, please contact Hendre on Hendre on Tel: +44 (0)1438 870 023 or email hmoolman@ckclinical.co.uk quoting 19282 to indicate your interest.
