Basic Purpose of the Job
To perform and maintain areas of responsibility with the BI UK Pharmacovigilance system ensuring the effective delivery of business objectives including 100% compliance with adverse event case processing, reporting timelines and data quality. Planning and executing tasks in a timely and precise manner and in accordance with BI policies, procedures and wider regulatory and legal requirements.
Accountabilities Deliver 100% compliance with respect to adverse event/reaction reporting timelines. Ensure ICSR processing is compliant with company procedures, including internal and regulatory timelines. Ensure follow-up information is requested in accordance with company procedures and timelines utilising the Product Quick Guide and query reports where appropriate. Key areas of responsibility within the local PV system are compliant with company procedures, legislation and regulation. This includes but is not limited to Literature Review, Malta Legislation Monitoring, Contingency Planning and timely Working Instruction and PV Repository updates. Develop strong cross-functional relationships and assist business partners in navigating and complying with PV relevant procedures. Providing accurate PV relevant advice by promoting and implementing current policies and guidance on PV Training, IIS and any other relevant projects. Key areas of responsibility within the local PV system are inspection ready. This includes contributing or leading process improvement initiatives to enhance current processes. Business partner and external customer communications are handled promptly and professionally, including Health Authority Requests.
Regulatory and / or Organisational Requirements Basic knowledge of European and International Pharmacovigilance regulations and laws. Thorough knowledge and understanding of the regulatory requirements in the UK, Ireland and Malta. Thorough knowledge and understanding of ICH-GCP requirements. Minimum of 2 years experience or equivalent within the Pharmacovigilance environment. Pharmacovigilance knowledge on a process and compliance level. Demonstrating a solid working knowledge of PV systems and processes and wider business functions. Contributing as a full team member, supporting others and sharing expertise and ideas. Proficient in all applicable BI systems and applications pertinent to the role. Excellent presentation/communication skills. Life Science degree or equivalent. Previous experience of pharmacovigilance and working within regulatory requirements within the pharmaceutical industry (essential). Understanding of the business impact of the pharmacovigilance function.
Required Capabilities (Skills, Experience, Competencies) Seeks opportunities to work as a team and share experience and knowledge. Offers constructive feedback and provides alternative suggestions or process improvements that continue to drive the department forward. Demonstrates negotiation and compromise skills whilst maintaining positive relationships and a 'can do' attitude. Expresses ideas clearly and concisely, verbally or in writing. Tailors communication to the level and experience of the audience. Excellent organizational, interpersonal and communication skills. Experience with the use and management of databases. Ability to prioritize work and to perform multiple functions. Demonstrates computer literacy, with proficiency in MS Windows, Excel, Word and Outlook.
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Accountabilities Deliver 100% compliance with respect to adverse event/reaction reporting timelines. Ensure ICSR processing is compliant with company procedures, including internal and regulatory timelines. Ensure follow-up information is requested in accordance with company procedures and timelines utilising the Product Quick Guide and query reports where appropriate. Key areas of responsibility within the local PV system are compliant with company procedures, legislation and regulation. This includes but is not limited to Literature Review, Malta Legislation Monitoring, Contingency Planning and timely Working Instruction and PV Repository updates. Develop strong cross-functional relationships and assist business partners in navigating and complying with PV relevant procedures. Providing accurate PV relevant advice by promoting and implementing current policies and guidance on PV Training, IIS and any other relevant projects. Key areas of responsibility within the local PV system are inspection ready. This includes contributing or leading process improvement initiatives to enhance current processes. Business partner and external customer communications are handled promptly and professionally, including Health Authority Requests.
Regulatory and / or Organisational Requirements Basic knowledge of European and International Pharmacovigilance regulations and laws. Thorough knowledge and understanding of the regulatory requirements in the UK, Ireland and Malta. Thorough knowledge and understanding of ICH-GCP requirements. Minimum of 2 years experience or equivalent within the Pharmacovigilance environment. Pharmacovigilance knowledge on a process and compliance level. Demonstrating a solid working knowledge of PV systems and processes and wider business functions. Contributing as a full team member, supporting others and sharing expertise and ideas. Proficient in all applicable BI systems and applications pertinent to the role. Excellent presentation/communication skills. Life Science degree or equivalent. Previous experience of pharmacovigilance and working within regulatory requirements within the pharmaceutical industry (essential). Understanding of the business impact of the pharmacovigilance function.
Required Capabilities (Skills, Experience, Competencies) Seeks opportunities to work as a team and share experience and knowledge. Offers constructive feedback and provides alternative suggestions or process improvements that continue to drive the department forward. Demonstrates negotiation and compromise skills whilst maintaining positive relationships and a 'can do' attitude. Expresses ideas clearly and concisely, verbally or in writing. Tailors communication to the level and experience of the audience. Excellent organizational, interpersonal and communication skills. Experience with the use and management of databases. Ability to prioritize work and to perform multiple functions. Demonstrates computer literacy, with proficiency in MS Windows, Excel, Word and Outlook.
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