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Pharmacovigilance Officer (one year project)

Job Mijdrecht, NL
Posted 2 Jun 2021

Degree level

Bachelor

Job function

Science

Required languages

Dutch (Fluent)
English (Fluent)

Work experience

0 to 5 years

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Pharmacovigilance Officer (one year project)

Mijdrecht

Fulltime


Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change

 

Pharmacovigilance Officer (one year project) 

 

Within our Medical Department, we are looking to strengthen the Pharmacovigilance (PV) team in Mijdrecht with a Junior Pharmacovigilance Officer (12 months contract). The PV team consists of 4 employees working in close collaboration. As a team we are responsible for all local activities related to the safety of our products for human use (divisions Consumer Health and Pharmaceuticals). We partner internally with local colleagues (e.g. Quality Assurance, Sales), the PV Regional Center in Prague and global colleagues. Additionally, we interact with Dutch health care professional, patients and consumers.

Your tasks and responsibilities:

PVO Case Management:

  • Handles all matters regarding AE/PTC handling in the PV team relating (but not limited) to:
  • Responsible for handling of safety data from all reporting sources to ensure timely processing in the Global Safety Database (Argus), as well as perform quality control (QC) steps
  • Liaises with the Local Quality Representative (LQR) in relation to Adverse Events (AE) reports associated with Product Technical Complaint (PTC) and aligns on actions
  • Performs follow-up/clarification activities of PV cases in a timely manner
  • Responsible for reconciliation of cases with internal functions and external partners.

 

PVO Process Management:

Executes a high-quality oversight of local PV process and compliance management by:

  • 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
  • Is involved in the preparation of the PV training given to the local organization (schedule, training material, organization). 
  • PVO Safety Management:
  • Supports handling of local safety topics and issues and contributes to appropriate use of Bayer’s products by:
  • Contributes to the handling of aggregate reports and SUSAR/line listings reporting to National Competent Authority (NCA), relevant ethics committees and investigators in the country
  • The PVO can be - as delegated by the PVCH - involved in Risk Management Plan activities, which may involve developing and implementing additional local risk minimization measures, with other stakeholders, where applicable
  • The PVO supports the PVCH in the provision of safety input into clinical, medical and commercial studies and projects.

Who you are

  • Bachelor’s or Master’s in Life Sciences
  • Experience in PV, Medical Information or Clinical Research activities is an advantage
  • Ability to adhere to procedures
  • Good communication skills in Dutch and English, both written and spoken
  • Strong sense of responsibility and conscientiousness, priority setting, organizing
  • Stress resistance and ability to comply with strict deadlines.

 

Your application

As a modern employer, we take care of our employees and help them find a balance between career development opportunities and personal life planning. We offer our employees a wide range of excellent career prospects around the world, a modern working environment and competitive compensation. We strive to hire the best, most talented people from around the world, and work to keep our employees as long as possible.

What Bayer offers you 

  • An attractive salary with 8% holiday pay and a bonus
  • 34 days of leave 
  • An inspiring working environment with professional and committed colleagues
  • A successful innovative organization with international career possibilities
  • Challenges and possibilities to learn and to develop
  • A good pension
  • An informal and friendly atmosphere.

 

For this position, we offer a Bayer contract of 12 months. In this position you have the choice to work 0%, 20% or 40% of your working hours from home. If you work from home, Bayer will provide an office chair, laptop stand, USB keyboard, USB mouse, cabled headset and USB extender, as well as an internet provision of €20,- net.

 

Interested in this vacancy?

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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power.

Chemical
Utrecht
15,000 employees