Pharmacovigilance and Medical Information Officer

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