Patient Safety & Pharmacovigilance Manager
Join to apply for the Patient Safety & Pharmacovigilance Manager role at Boehringer Ingelheim
Patient Safety & Pharmacovigilance Manager
Join to apply for the Patient Safety & Pharmacovigilance Manager role at Boehringer Ingelheim
Patient Safety and Pharmacovigilance (PSPV) Manager
Are you passionate about ensuring patient safety and compliance in the pharmaceutical industry? Join us as a PSPV Manager and play a pivotal role in safeguarding public health!
Role Overview: As a PSPV Manager, you will support and manage Pharmacovigilance (PV) Operations, creating and maintaining local PV policies and procedures. You will work closely with the Head of PSPV to establish and maintain a local PV system that complies with internal procedures and external regulations. Your role will ensure that Boehringer Ingelheim UK and Ireland fully comply with Pharmacovigilance regulations and meet the requirements of key local and global internal and external stakeholders.
Key Responsibilities:
* Compliance and Reporting: Ensuring implementation and maintenance of robust safety reporting compliance in accordance with current applicable regulations.
* Policy & Training Implementation: Create, implement, and maintain local PV policies and procedures alongside ensuring robust training plans and record management.
* Stakeholder Management: Support oversight planning and management of key external stakeholders and suppliers.
* Driving Strategic PSPV Integration in Therapeutic Projects: Support enhanced PSPV awareness and visibility initiatives through initiating cross-functional collaborations and securing representation in asset and evidence teams within targeted therapeutic areas to enable driving PSPV involvement and fostering collaboration in these settings for holistic evidence generation and launch readiness.
* Regulatory Intelligence: Screening of applicable regulatory and health authority sites, critically evaluate and assess the impact and update of regulatory intelligence systems and tools accordingly.
* Safety Surveillance & Reporting: Perform routine safety surveillance safety data review and signal management activities in a compliant and timely manner.
* Process Improvement: Lead process improvement initiatives and innovation to enhance PV processes and ensure compliance and inspection readiness.
* Mentorship: Mentor junior colleagues and act as a subject matter expert in applicable activities within scope.
* Support and Succession: Support the Head of PSPV in business contingency. Act as liaison when required by Head of PSPV as cross-functional relationship manager to ensure successful execution and maintenance of PSPV operations, support successful tactical implementation of departmental strategic goals and objectives.
* Routine PV Operations: Support the Head of PSPV in management of the Pharmacovigilance System Master File maintenance, Business Contingency, PV QMS and Key Performance Indicator management and PV Repository and Frameworks.
Required Competencies:
* Medical, Pharmacy, or Life Sciences degree. Advance professional degree preferred.
* Minimum of 6 years of relevant progressively responsible experience in Pharmacovigilance Operations or combined PV/RA/QA experience.
* Extensive experience working with suppliers, internal and external stakeholder relationship management and desired experience in liaising with local Health Authorities.
* In-depth understanding of Pharmacovigilance regulations for both marketed and investigational products, and excellent knowledge of local (and/or global) health authority requirements, including ICH, CFR 21, EU GVP modules. Strong organizational, interpersonal, presentation and communication skills.
* Experience with the use and navigation of safety databases.
* Experience in maintaining and navigating Quality Management Systems for pharmacovigilance processes and operations.
* Audit and inspection support experience for PV and PV-related audits and inspections.
* Experience in planning, allocating and managing PV-related projects in a matrixed, fast-paced, regulated and cross functional environment.
* Ability to prioritize work and perform multiple tasks while maintaining high standards.
* Proven experience in quality and process improvement in PV operations.
Why Join Us?
* Impactful Work: Contribute to the safety and well-being of patients by ensuring compliance with Pharmacovigilance regulations.
* Collaborative Environment: Work with a dynamic team of professionals dedicated to excellence in patient safety.
* Professional Growth: Opportunities for continuous learning and development in a supportive environment.
Our Company
Why Boehringer Ingelheim?
With us, you can develop your own path in a company with a culture that knows our differences are our strengths \u2013 and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after \u2013 as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Pharmaceutical Manufacturing
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