For more information, please contact Hendre Moolman at CK Clinical on 01438 870 023 or emaail hmoolman@ckclinical.co.uk.

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

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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.

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Senior Medical Information Executive

• Location: Buckinghamshire
• Status: Permanent
• Company: Pharmaceutical
• Salary: Up to early £40’s
• Ref: 21114

A new opportunity is available to join an established pharmaceutical company in Buckinghamshire as a Senior Medical Information Executive. You will be involved in a broad range of activities, including assisting the Medical Affairs Manager to ensure the smooth day to day running of the UK Medical Information Function. You will provide medical information support to Sales and Marketing Departments, including copy approval work. You role will require you t o assist in the maintenance of internal Medical Information databases as well as mentoring and supporting other Medical Information.

Senior Compliance Executive

• Location: Buckinghamshire
• Status: Permanent
• Company: Pharmaceutical
• Salary: Up to £50,000
• Ref: 21169

An exciting opportunity as Senior Compliance Executive has arisen to join an established pharmaceutical company in Buckinghamshire. In this position you will contribute towards developing, implementing and maintaining company policies and procedures covering activities governed by the ABPI Code of Practice for the Pharmaceutical Industry. You will provide central guidance and training on the ABPI Code of Practice and oversee and manage the Zinc MAPS system for promotional materials.

Drug Safety Manager

• Location: Surrey
• Status: Permanent
• Company: Pharmaceutical
• Salary: Up to £57k pa
• Ref: 20623

We are recruiting for a Drug Safety Manager to join an established Pharmaceutical company in Surrey. 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. You will need to manage resources in the safety team depending on local organisation and safety group size. Proven and in depth Drug Safety experience is required for the role. The role will have a strong focus on Case Processing.

EU Medical Information Advisor

• Location: Bedfordshire
• Status: Permanent
• Company:  Pharmaceutical
• Salary: Up to £44k pa
• Ref: 21031

We are recruiting for a EU Medical Information Advisor to join an established Pharmaceutical company in Bedfordshire. As a Medical Information Advisor you will provide a high quality, comprehensive, technical and scientific information service for external customers on the company’s product range, supporting and enhancing the safe and effective use of products, enabling our customers to make informed decisions about the company product range. This will be a second-line support role with a strong focus on working with the EU teams on brand related areas. Experience in Copy Approval would be really beneficial.

Clinical Safety Officer – Contract

• Location: Buckinghamshire
• Status: Contract
• Company:  Pharmaceutical
• Salary: Up to £25 phr
• Ref: 20417

We are recruiting for a contract Clinical Safety Scientist to join a pharmaceutical company based in Buckinghamshire. As a Clinical Safety Scientist you will process and evaluate Serious Adverse Events (SAEs) received from clinical trials. You will support drug development, i.e. data entry, evaluation, follow up activities with CROs, QC and triage of cases from other sites. You will need to have experience in expediting reports, preparing  line listings, SAE reconciliation, and maintaining compliance with local and global regulatory reporting. A life science degree combined with proven drug safety experience is required for this role.

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.

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Our client, a  leading pharmaceutical company, are currently recruiting for a Drug Safety Associate to join their team based in Buckinghamshire, on a contract basis. You will 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.

Key responsibilities of this Drug Safety Associate role 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.
• Preparation of deviation memo as necessary.
• Request deletions as necessary.
• Single case unblinding.
• Understand relevant safety implications regarding contracts with operating companies and/or marketing partners.
• Review and make suggestions for system and procedure enhancements.
• Participation in inspections and audits, as required.
• Participation in local or global project teams.

This position is to work on a oncology drug, therefore experience in oncology and the Argus database is a bonus to hit the ground running (but not essential).

• Candidates must have a Life Science degree or be a qualified nurse.
• Pharmacists are not suited unless they have recent experience in Drug Safety.
• Reasonably local people are preferred.

Successful candidates will enjoy the benefits of working with a global Pharmaceutical company, including a competitive rate as well as ongoing professional development.

If you would like to hear more about this Drug Safety Associate role, please contact Hendre on Tel: +44 (0)1438 870 023 or email me at hmoolman@ckclinical.co.uk quoting 19124 to indicate your interest.

Apply for this Drug Safety Associate job now.

Keywords: Drug Safety Officer, Pharmacovigilance Officer, Drug Safety Associate, Pharmacovigilance Associate, Contract, Argus, Life Science, Literature, Case processing.

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry. 

Working as a Senior Data Associate in Drug Safety you will be responsible for the following:

• Adverse Event case management:          
  • Initial assessment and classification.
  • Perform follow-up review and close individual case safety reports.
  • Review case narratives.
  • Facilitate and ensure medical review of all adverse events from clinical trials and commercial use.
• Participating in Pharmacovigilance reviews, identify/collate adverse event case series, assist in event signaling.
• Identifying expedited reports and ensuring their timely evaluation and preparation for submission to regulatory authorities. 
• Participating in PSUR preparation. 
• Participating in the Post marketing and Clinical Trial Case Review Meetings.
• Ongoing identification and implementation of safety process refinements.
• Performing other duties as requested by Pharmacovigilance management.

The successful candidate will be educated to a minimum degree level in Biomedical Science, Pharmacy or Nursing and will have previous experience in Drug Safety and Clinical Trials. It is also essential that you have previous working experience in post marketing drug safety, clinical trial safety and pharmacovigilance.

This is a fantastic opportunity for an experienced Senior Data Associate to assist this global pharmaceutical company to meet the unmet medical needs of patients in more than 90 countries.

If you would like more information about this role, please contact Hendre Moolman on 01432 743047 or email hmoolman@ckclinical.co.uk. Alternatively, to apply for this Senior Data Associate job, click here.

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Year in and year out the PIPA conference is always welcoming and a valuable networking opportunity for the CK Clinical Medical information recruitment and drug safety recruitment team and this year was no exception.

The conference gave us the opportunity to pick up new medical information jobs from some of our valued customers that we have worked with for years as well as develop relationships with some new customers to help them recruit for their drug safety jobs. We look forward to working with you