Emplois actuels liés à Pharmacovigilance Officer Bnl - Diegem, Flandre - Bayer
-
Brand Manager Consumer Health Bnl
Il y a 4 mois
Diegem, Belgique Bayer Temps plein**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...
-
Customer Service Assistant
Il y a 3 mois
Diegem, Belgique MAXXIUM BELGIUM Temps pleinIl agira en tant qu'agent de liaison, fournira des informations sur les produits/services, répondra aux questions et résoudra tout problème émergent auquel nos comptes clients pourraient être confrontés avec précision et efficacité dans le processus OTC. Rattaché au Supply Chain Manager, vous serez en charge de: Portée OTC complète dans la...
-
Project Support Officer Established Products
Il y a 4 mois
Diegem, Belgique Bayer Temps plein**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...
-
Project Support Officer Market Access
Il y a 3 mois
Diegem, Belgique Bayer Temps plein**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...
-
Customer Service Representative
Il y a 4 mois
Diegem, Belgique 3M Temps pleinJob Description: Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies...
-
Account Manager Cardio
Il y a 3 mois
Diegem, Belgique Bayer Temps plein**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...
-
Customer Engagement Specialist Cardio
Il y a 3 mois
Diegem, Belgique Bayer Temps plein**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...
Pharmacovigilance Officer Bnl
Il y a 3 mois
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.
Pharmacovigilance Officer BNL
The contribution of the PVO is necessary to maintain the compliance of the ICSRs towards Pharmacovigilance and NCA. He/she contributes to assure patients' safety by complying with all PV Quality System Documents (QSDs) and local and international regulatory requirements
YOUR TASKS AND RESPONSIBILITIES
- The Pharmacovigilance Officer (PVO) position belongs to the local Pharmacovigilance (PV) department The main purpose of the position is to ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing expertise.
- Handles all matters regarding AE/PTC handling in the PV team relating (but not limited) to:
- Responsible for case receipt, translation related activities and transfer to SDRA where applicable.
- Performs followup activities of ICSRs in a timely manner.
- Responsible for reconciliation of cases with internal functions and external partners.
- Performs the submission of the ICSRs to HA in accordance with the national regulations.
- Executes a highquality oversight of local PV process and compliance management by:
- Assisting with local PV CAPA management activities. The PVO is also expected to overview PV quality of various programs and projects initiated by internal stakeholders.
- Contributing to audits, inspections and contract management.
- Being involved in the preparation of the PV training given to the local organization (schedule, training material, organization).
- Conducting the local literature search for AEs.
- Supports handling of local safety topics and issues and contributes to appropriate use of Bayer's products by:
- Contributing 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.
- Participating 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.
The main objective of the function is:
- 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.
By focusing on prescription products in cardiology and women's health, we propose new treatments for cardiovascular diseases and drive innovation for women.
By concentrating on specialty therapeutics in the areas of oncology, hematology and ophthalmology, we fight cancer, treat hemophilia and protect vision.
Our mission is to research, develop, manufacture and market specialized products that improve the health of people throughout the world.
Are you just as committed, focused and passionate as we are about shaping the future of health care?WHO YOU ARE
- Life science graduate (preferably healthcare professional).
- Experience in pharmacovigilance activities (ideally 2 or more years).
- Good knowledge of medical terminology.
- Detailminded and taskoriented person.
- Ability to adhere to procedures.
- Ability to communicate orally and in writing in the local language and English.
- Excellent administrative skills.
- Good computer knowledge.
- Strong sense of responsibility and conscientiousness, priority setting, organizing.
WHAT BAYER OFFERS YOU
As a modern employer, we take care of our employees and help them find a balance between career development opportunities and personal life planning.
