The role has been created to meet the continued growth of the business. We are now searching for an enthusiastic individual with great attention to detail, proactive and well-organised mindset to join our growing Pharmacovigilance and Medical information team.
Please be aware this role is office based, our office is in Hertford, UK.
Role Responsibilities
Key activities include:
· Responsible for continuing development and maintenance of the AE reporting processes and system.
· Responding to Medical Information (MI) enquiries
· Execute literature searches to identify key product articles
· Creation and collation of aggregate reports (PSURs, RMPs, Renewals etc,)
· Perform reconciliation activities of received medical Information enquiries, product complaints and adverse events with other internal and/or external stakeholders as required;
· Support the collation of PV/MI Compliance metrics, Key Performance Indicators (KPI) and Quality Review reports;
· Providing support in preparation for internal and external audits
· Keep current with professional and pharmacovigilance regulations and knowledge
· Constantly works towards identification of new training and development opportunities for the PV department.
· Ensuring all 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 SOPs, regulatory requirements, and contractual obligations.
· 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
· Liaising with partners 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 inputs
· Maintaining knowledge and understanding of safety related regulations and guidelines
· Performing other duties as identified and requested by management
· Providing administrative support to the Pharmacovigilance Team as required
· Develop and maintain a thorough knowledge of the company’s products;
· Represent Pharmacovigilance and medical information in cross-functional team meetings, as required.
Key Skills, Knowledge and Experience
· At least one year of demonstrable relevant experience working in the pharmaceutical industry is preferred.
· A willingness to learn and grow with the team is essential
· BSc or equivalent Life Sciences Degree
· Excellent communication skills, written and oral and fluent in English
· Excellent planning and organising skills, proven ability to multi-task
· Flexible and pro-active approach, can work effectively in a team environment
· Good attention to detail and evidence of ability to work under pressure
· Able to build relationships with key internal and external customers and demonstrate customer focus, proven experience of working to meet high standards and provide excellent customer service
