International Affiliate Drug Safety Governance Specialist
An internationally known biotechnology company has an opening for an International Affiliate Drug Safety Governance Specialist job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.
- Supporting and facilitating the implementation and ongoing management of the overarching Pharmacovigilance strategy.
- Contributing to IPV oversight of Affiliates, Vendors and International Partners including compliance and quality governance and oversight of safety report collection in the post-marketing space.
- Supporting Adverse Event (AE) reconciliation activities as applicable.
- Supporting IPV leadership in the development and ongoing management of technology solutions used to compliment the oversight strategy and day-to-day PV activities conducted across the network.
- Assisting with quality improvement activities relating to global collection of adverse events to facilitate harmonization, efficiency and clarity of processes. This includes utilising empirical data (quantitative and qualitative) to help inform IPV Leadership of areas of opportunity.
- Contributing to the mechanisms needed to oversee appropriate training of case handling procedures and systems to ensure adequate AE collection globally. This includes updating of relevant materials and the ongoing monitoring to ensure they are fit for purpose.
- Assisting with the IPV controlled document management lifecycle, including authoring, updating and monitoring of Standard Operating Procedures (SOPs), Job Aids, R&D Business Processes, Work Instructions and reporting forms.
- Supporting the PV Governance process as is applicable to Organised Data Collection Programs (ODCPs) for AE collection to ensure consistency with regulations and with departmental goals and objectives.
- Working with IPV management to ensure there is continuous line-of-sight for Global Digital and Social Media activities that allow for User Generated Content (UGC).
- Ensuring there is continuous monitoring of these activities to confirm compliance with Pharmacovigilance requirements.
- Providing support to IPV Management with technology solutions that facilitate the reporting of Adverse Events e.g. local Mobile Platform Applications (APPs).
- Supports the collection, analysis, communication and operational change management process for Regulatory Intelligence related to Pharmacovigilance in the Affiliate and International Partner Market (IPM) space as required.
- Contributing to other projects related to IPV and GSRS as required.
Skills and Requirements:
- Minimum of bachelor's level degree. In a Science or Healthcare related area is preferred.
- Highly motivated and a self-starter.
- Good written and verbal communication skills including.
- Good technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills.
- Strong Information Technology (IT skills); familiar with common software such as Microsoft Word, Excel, PowerPoint, Outlook.
- Ability to work effectively both independently and as part of a team.
- Experience of working in the Pharmaceutical Industry required.
- Experience in drug safety/PV is preferred.
- Knowledge of Good PV Practices preferred.
- Fluency in English (written and verbal) is required.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Hansberry at 0207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.