At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
PV Officer
Major Tasks
• The contribution of the PVO is necessary to maintain the compliance of the ICSRs towards Pharmacovigilance and NCA. The PVO contributes to the maintenance/improvement of the quality of the ICSRs.
• Ensures compliance with respect to QSDs, local and international safety regulations and legal requirements and also remains current with changing regulatory requirements.
• Contributes to the implementation and maintenance of risk minimisation measures and helps ensure all relevant stakeholders understand the importance of these measures.
• Build and foster relationships with internal and external stakeholders through effective communication and collaboration in order to ensure patient safety, regulatory obligations and that PV processes are upheld.
• Proactively contributes to the ‘best practice’ environment in Pharmacovigilance in the country while balancing needs of external customers and stakeholders. Executes a high-quality oversight of local PV process and compliance management.
• Monitoring of local PV regulation and QSD management.
• Assists with local PV CAPA management activities.
• The PVO is also expected to overview PV quality of various programs and projects initiated by internal stakeholders.
• Contributes to audits, inspections and contract management. Supports handling of local safety topics and issues and contributes to appropriate use of Bayer’s products
• Contributes to the handling and generation of aggregate reports and SUSAR/line listings reporting to National Competent Authority (NCA), relevant ethics committees and investigators in the country, where applicable.
• Participates in local safety issue management activities as requested by the PVCH.
• The PVO can be delegated by the PVCH to be involved in Risk Management Plan activities, which may involve developing and implementing additional local risk minimization measures, with other stakeholders, where applicable. Supports activities regarding AE/PTC handling in the PV team
• Case receipt and transfer to Argus. Clarification and follow-up of ICSRs
• Liaises with the Local Quality Representative (LQR) in relation to AE reports associated with Product Technical Complaint (PTC) and aligns on actions.
• Supports reconciliation of cases with internal functions and external partners.
• Performs the submission of the ICSRs to HA in accordance with the national regulations.
Who you are?
• Life science graduate (preferably health-care professional)
• Experience in pharmacovigilance activities (desirable)
• Can demonstrate good knowledge of medical terminology
• Detail-minded and task-oriented person
• Ability to adhere to procedures
• Good communication skills both written and orally
• Excellent administrative skills
• Good computer knowledge
• Strong sense of responsibility and conscientiousness, priority setting, organizing
• Stress resistance and ability to comply with strict deadlines
Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.
To achieve our vision we see reward for all our employees as incredibly important and include the following list of benefits and working conditions:
- competitive salary and performance bonus
- 28 days annual leave plus bank holidays
- Private Healthcare, generous pension scheme and Life Insurance
- Employee discount scheme
- State of the art offices
- International career possibilities
- Flexible and remote working
#LI-UK
#Hybrid
Bayer welcomes applications from all individuals, regardless of age, disability, gender identity/expression, family status, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. We are committed to treating all applicants fairly and without discrimination. We continue to progressively embrace and adopt actions to advance our Diversity Equity & Inclusion (DE&I) commitments and aspirations, #ForBetter.
Bayer is committed to providing access and support for all individuals with disabilities - during the application process and beyond. Applicants with disabilities are encouraged to request any support / equipment they may need via the contact information below.
Location:
United Kingdom : Berkshire : Reading
Division:
Pharmaceuticals
Reference Code:
813933
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