Job Description
The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.
Main responsibilities
* Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance 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
* Preparation and collection of documentation for submissions to the regulatory authorities
* Review and linguistic input on local Product Information and Mock-ups
* Development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations
* Perform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
* Maintain accurate records and documentation at local level
* Provide support to the RA & PV Global operations team
* Ensure compliance with MAH's and PrimeVigilance's procedures
* Support audits and Inspections
* Handle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market
Qualifications
* Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
* Previous Pharmaceutical or CRO industry or regulatory authority
* Previous experience within LCPPV role, or relevant pharmacovigilance experience in safety-related position
* Pharmacovigilance training and/or working experience and other educational or professional background as required by local regulations
* Prior experience in Regulatory Affairs is preferred but not mandatory
* Expert knowledge of ICH GVP and relevant local legislation/ regulatory requirements in territories of competency
* Proficiency in English and Dutch, both written and verbal
* Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint
Additional Information
Why PrimeVigilance
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.
We offer:
* Training and career development opportunities internally
* Strong emphasis on personal and professional growth
* Friendly, supportive working environment
* Opportunity to work with colleagues based all over the world, with English as the company language
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.
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