Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
Due to our constant growth, we are looking for a National/Local Contact Person for Pharmacovigilance for Germany to join our Global Pharmacovigilance- Team.
You will be responsible for:
* Act as the main point of contact for national regulatory authorities regarding pharmacovigilance matters
* Assure to have a background and experience in line with the local contact person requirements
* Tacking care of the notification to the local competent authority of the role and to provide with all necessary documentation for completing the registration
* Ensure timely collection, translation, evaluation, and reporting to global of adverse drug reactions (ADRs) in accordance with local regulations and SOPs
* Maintain up-to-date knowledge of national pharmacovigilance regulations and implement changes as necessary and inform the global about any impact of company processes
* Weekly screen the local scientific journals for detecting safety information and adverse event
* Collaborate with the global pharmacovigilance team to ensure alignment of processes and best practices
* Support the global team in collecting data for the periodic safety reports and PSMF
* Perform any other PV activity specifically required by local regulation (e.g. signal detection, complaints management and reporting, etc)
* Perform reconciliation with internal sources, with global team and with partners
* Train and support local staff involved in pharmacovigilance activities
* Ensure that the local pharmacovigilance system is adequately documented and operational
* Provide support during audits and inspections conducted by local health authorities
About you:
* Bachelor’s or Master’s degree in pharmacy, medicine, life sciences, or a related field
* Minimum 3 years of experience in pharmacovigilance or a related regulatory function
* In-depth knowledge of local pharmacovigilance requirements in the assigned country
* Excellent communication and organizational skills
* Fluent in both written and spoken the local language (German). Proficiency in both written and spoken English
* Ability to work independently and manage multiple tasks efficiently
* Experience with safety databases and pharmacovigilance software is preferred
Working Conditions:
* Freelance contract/ Employment contract
* Remote
* Part time/ full time
* Flexibility to travel if required for training or regulatory meetings
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.