We are a global accredited early phase CRO that delivers clinical excellence from design to delivery. We pride ourselves on providing a personal service to our clients ensuring the quality, integrity, and accuracy of studies throughout. At RPL, our diverse and experienced team take pioneering, creative and flexible approaches and implement them with efficiency, quality, and excellence.  

Richmond Pharmacology is an innovative, dynamic, and adaptive CRO based uniquely in central London with excellent transportation links, conducting clinical research on behalf of the pharmaceutical industry.

We are now searching for an enthusiastic individual with great attention to detail, proactive and well-organised mindset to join a growing Pharmacovigilance team. This individual with have the chance to further their experience and knowledge within a well-structured research environment as a Pharmacovigilance Associate.

The individual would be required to recognise, exemplify, and adhere to RPL’s values which centres around our commitment to efficiency quality and excellence.

Role Responsibilities

With guidance and oversight, key activities include:

Review and processing serious adverse events, spontaneously reported adverse reactions and/or other medically related project information such as adverse events of special interest and clinical end points.

Ensuring all RPL, Sponsor and regulatory timeframes are met for the processing and reporting of safety information.

Assisting in ensuring the completion of all departmental project activities accurately in accordance with RPL SOPs, study operating manuals, regulatory requirements, and contractual obligations to Sponsors/Sponsor processes.

Providing input and review relevant safety tracking systems for accuracy and quality.

Ensuring good documentation practice and all documentation pertaining to safety are maintained in the project files

Performing safety review of clinical and diagnostic data

Liaising with sponsor and internal departments as necessary for issues related to safety including attending internal and client meetings as required

Assisting with coordination of interdepartmental activities (e.g., listing review, quality control, audits and inspections and miscellaneous project activities)

Reviewing key study documentation for Pharmacovigilance input

Maintaining knowledge and understanding of safety related regulations and guidelines

Mentoring or training of new Pharmacovigilance staff

Contributing to agreed Pharmacovigilance team targets and goals

Performing other duties as identified and requested by management

Maintaining safety templates and forms

Providing administrative support to the Pharmacovigilance Team as required

Key Skills, Knowledge and Experience:

Excellent planning and organising skills, proven ability to multi-task

Flexible and pro-active approach

Good communication skills, written, oral and fluent in English

Ability to maintain rigorous adherence to written procedures, e.g., SOPs

Excellent attention to detail and accuracy

Ability to work on own initiative at times

Enthusiastic and motivated

Works effectively within a team environment

Essentials:

Biological Sciences degree or equivalent nursing qualifications/experience

Experience of working in Pharmacovigilance, ideally in clinical trials but not essential. However candidates experience should cover full case processing (from receipt to submission), data review activities including analysis of safety data.

Good understanding of medical and scientific terminology, clinical trial methodology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements.

Computer/technical literacy including Microsoft Office

Experience of working with a safety database

Desirables

Experience of working with MedDRA coding dictionary

Experience of using validated systems including Quality Management Systems and Clinical Databases (e.g., RAVE, In Form etc)

Experience in reviewing clinical trial documentation, e.g., Protocol, investigator Brochure's, Safety Reporting Plans etc

Experience in providing internal or external Pharmacovigilance training

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