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- Tasks: Be the go-to person for local regulatory compliance in pharmacovigilance and regulatory affairs.
- Company: Join PrimeVigilance, a global leader in pharmacovigilance services dedicated to patient safety.
- Benefits: Enjoy training opportunities, a supportive environment, and a focus on work-life balance.
- Other info: This is an entry-level, full-time remote position with global collaboration.
- Why this job: Make a real impact on patient lives while growing your career in a diverse workplace.
- Qualifications: Bachelor's in Life Sciences or related field; experience in pharma or regulatory roles preferred.
The predicted salary is between 30000 - 42000 £ per year.
Overview
Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) – English & Dutch languages required. Role at PrimeVigilance.
Company: PrimeVigilance (part of Ergomed Group) is a specialised pharmacovigilance service provider with a global presence and services across Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. We invest in staff through training and development, value employee well-being and work-life balance, and strive to make a positive impact in patients’ lives.
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 executes 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 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 websites for potential 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 investigations into suspected falsified products and quality alerts from health authorities
Qualifications
- Bachelor\’s Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
- Experience in Pharmaceutical/CRO industry or regulatory authority
- Prior LCPPV or relevant pharmacovigilance experience in a safety-related position
- Pharmacovigilance training and/or working experience as required by local regulations
- Regulatory Affairs experience is preferred but not mandatory
- Expert knowledge of ICH GVP and local legislation/regulatory requirements in territories of competency
- Proficiency in English and Dutch (written and verbal)
- Strong skills in Microsoft Word, Excel, and PowerPoint
Why PrimeVigilance
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment. We value employee experience, well-being and mental health and support a healthy work life balance to achieve high-quality client service.
We Offer
- Training and career development opportunities
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues worldwide, with English as the company language
Additional Information
Remote
Seniority level
Entry level
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Pharmaceutical Manufacturing
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Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Dut[...] employer: PrimeVigilance
Contact Detail:
PrimeVigilance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Dut[...]
✨Tip Number 1
Familiarise yourself with the local regulatory landscape in pharmacovigilance and regulatory affairs. Understanding the specific requirements and guidelines in your region will not only help you during interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the pharmacovigilance and regulatory affairs sectors. Attend industry events, webinars, or join relevant online forums to connect with others in the field. This can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in pharmacovigilance regulations. Subscribe to industry newsletters or follow key organisations on social media to ensure you're informed about any new developments that could impact your role.
✨Tip Number 4
Prepare for potential interview questions by practising your responses to common scenarios in pharmacovigilance and regulatory affairs. Think about how you would handle specific challenges or compliance issues, as this will showcase your problem-solving skills.
We think you need these skills to ace Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Dut[...]
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of the Local Contact Person for Pharmacovigilance and Regulatory Affairs. Familiarise yourself with pharmacovigilance and regulatory affairs concepts to demonstrate your knowledge in your application.
Tailor Your CV: Customise your CV to highlight relevant experience in pharmacovigilance, regulatory affairs, or related fields. Emphasise any specific training or qualifications that align with the job requirements, especially your proficiency in English and Dutch.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention how your background in life sciences or chemistry, along with your experience in the pharmaceutical industry, makes you a suitable candidate for this position.
Highlight Soft Skills: In your application, don't forget to mention soft skills such as communication, attention to detail, and problem-solving abilities. These are crucial for the role, especially when dealing with local regulatory authorities and ensuring compliance.
How to prepare for a job interview at PrimeVigilance
✨Know Your Regulations
Familiarise yourself with local pharmacovigilance and regulatory requirements. Being able to discuss specific regulations and how they apply to the role will show your expertise and preparedness.
✨Demonstrate Communication Skills
As a primary contact for local regulatory authorities, effective communication is key. Prepare examples of how you've successfully communicated complex information in previous roles, especially in English and Dutch.
✨Showcase Your Experience
Highlight any relevant experience in pharmacovigilance or regulatory affairs. Be ready to discuss your previous roles, particularly any direct interactions with regulatory bodies or handling of adverse drug reactions.
✨Emphasise Team Collaboration
This role involves working closely with global operations teams. Share examples of how you've collaborated with others in past positions, focusing on teamwork and achieving common goals.