Pharmacovigilance Scientist
Pharmacovigilance Scientist
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Pharmacovigilance Scientist
Job Location: Bracknell UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
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 followup 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 crossfunctional 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 ICHGCP 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
Our Company
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and familyowned ever since Boehringer Ingelheim takes a longterm perspective. Now we are powered by 52000 employees globally who nurture a diverse collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation there is no limit to what we can achieve.
Why Boehringer Ingelheim
With us you can grow collaborate innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition learning and development for all employees is key because your growth is our growth.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees patients and communities.
Want to learn more Visit
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 followup 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 crossfunctional 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 ICHGCP 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
Our Company
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and familyowned ever since Boehringer Ingelheim takes a longterm perspective. Now we are powered by 52000 employees globally who nurture a diverse collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation there is no limit to what we can achieve.
Why Boehringer Ingelheim
With us you can grow collaborate innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition learning and development for all employees is key because your growth is our growth.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees patients and communities.
Want to learn more Visit
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Employment Type
Full Time
Key Skills
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