Local Drug Safety Officer - Pharmacovigilance

Posted 16 Dec 2021

Wroclaw, Dolnoslaskie - Poland

Req Id 232786

Details

 

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


Your role:

 

Local Drug Safety Officer will be directly accountable for performing all Pharmacovigilance (PV) related tasks in Poland and will be nominated as the responsible person to the Health Authority.

You will establish and maintain the local PV System according to global/local legislation and our Global Patient Safety standards.
 

We expect you to supervise performance and compliance of the local PV system and maintain key performing indicators within expected standards for all PV activity timelines and ensuring documentation is carried out with the respective country/region.
Providing input to the design and development of Patient Support Programs and other Patient Data Collection Systems such as Market Research Programs, Digital Media Programs etc will be one of the tasks. In addition to that you will monitor local PV regulations in Poland, inform GPS on any changes with an impact on distribution rules or other PV activities, and act accordingly on the changes.

 

Local Drug Safety Officer will evaluate local updates of PV regulations in collaboration with the GPS PV Intelligence Team and complete impact assessment activities in accordance with required standards. Assigned person will also act as first point of contact to local PV related audits or Health Authority inspections as requested, supporting CAPA proposals, implementation and CAPA efficiency evaluation.

 

Are you ready for this challenge?

 

Who you are:

  • You have a minimum of 5 years of experience in Pharmacovigilance

  • You have a University Degree in health care or life sciences related areas (i.e. Clinical Research, Medical or Regulatory Affairs) in the pharma industry/health authority

  • You possess a strong team-working skill - working across cultural and functional boundaries and participating in "virtual teams"

  • You have proven communication skills and process management experience

  • You are proficient in written and spoken Polish and English languags

 


 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

 

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