Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
Job Description
This is an exciting opportuniy for a freelancer / consultant to join our team as Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE.
By working with us, you will have the opportunity to work in an international team and strength your expertise within the broad and diverse PV and Regulatory Affairs area.
Main responsibilities
Primary contact person for local regulatory authority / Pharmacovigilance expert as per local requirements
Prompt and effective communication with local regulatory authorities
Provision of local regulatory intelligence screening and expert advice
Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
Review and linguistic input on local Product Information and Mock-ups
Perform local non-indexed literature screening and screening of Regulatory Authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
Support audits and Inspections
Handle local QA tasks such as suspected falsified products, quality alerts received from HA) and other quality-related requirements received from the local market
Qualifications
Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience
Demonstrated experience within pharmaceutical or CRO industry or Regulatory body
Must have experience within LCPPV / LCPRA roles
PV training and/or working experience and other educational or professional background as required locally
Expert knowledge of ICH GVP and most relevant legislation/ local requirements for territories of competency
Proficiency in English, both written and verbal and in local language
Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
Must currently be set up to work as a freelancer / consultant
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.