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- Tasks: Lead regulatory projects and ensure compliance with industry standards.
- Company: Join a diverse and inclusive team at PrimeVigilance.
- Benefits: Training, career development, and a supportive remote work environment.
- Why this job: Make a real impact in the pharmaceutical industry while growing your skills.
- Qualifications: Bachelor's in Chemistry or Life Sciences; experience in pharma/CRO preferred.
- Other info: Collaborate globally and thrive in a fast-paced, dynamic setting.
The predicted salary is between 40000 - 50000 £ per year.
The Specialist, Regulatory and PV Network (Delivery) is responsible for providing the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies. The Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.
Responsibilities
- Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
- Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs and core documents). Support identification of issues and corrective actions.
- Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports.
- Ensure correct training assignment to and training compliance by the LCPs.
- Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
- Provide Clients expertise and guidance at national level.
- Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
- Prepare client’s invoices and review/approve vendors’ project invoices.
- Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
- Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
- Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
- Track LCPs' key performance indicators and prepare monthly summary reports.
- Provide feedback on performance of vendors to aid their assessment.
- Communicate suggestions for changes to departmental/company processes/procedures.
- May act as Local Contact Person for Pharmacovigilance or deputy.
Qualifications
- Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.
- Previous experience within the pharmaceutical/CRO industry.
- PV training and/or working experience and other educational or professional background as required locally.
- Fluent in English, both written and verbal.
- Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance.
- Good planning and organizational skills.
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment.
- Good attention to detail.
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.
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.
Specialist, Regulatory and Pharmacovigilance Network (Delivery)- remote in UK in Glasgow employer: Ergomed
Contact Detail:
Ergomed Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Specialist, Regulatory and Pharmacovigilance Network (Delivery)- remote in UK in Glasgow
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at companies you're interested in. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by researching common questions in regulatory and pharmacovigilance roles. Practise your answers with a friend or in front of a mirror. Confidence is key, and knowing your stuff will help you shine!
✨Tip Number 3
Showcase your skills! Create a portfolio or a presentation that highlights your relevant experience and achievements. This can set you apart from other candidates and give interviewers a clear picture of what you bring to the table.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Specialist, Regulatory and Pharmacovigilance Network (Delivery)- remote in UK in Glasgow
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Specialist, Regulatory and Pharmacovigilance Network. Highlight relevant experience in regulatory requirements and pharmacovigilance, as well as any project management skills that align with the job description.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Use specific examples from your past experiences that demonstrate your ability to manage deliverables and liaise effectively with various stakeholders.
Showcase Your Attention to Detail: Since this role requires good attention to detail, make sure your application is free from typos and errors. This will show us that you take pride in your work and understand the importance of accuracy in regulatory tasks.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates regarding your application status.
How to prepare for a job interview at Ergomed
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory requirements and pharmacovigilance practices. Familiarise yourself with the specific regulations relevant to the role, as this will show your potential employer that you're serious about the position and understand the landscape.
✨Showcase Your Project Management Skills
Be ready to discuss your experience in managing projects, especially those of low complexity. Prepare examples where you've coordinated deliverables and met targets, as this aligns perfectly with the responsibilities of the role.
✨Build Rapport with Your Interviewers
Since this role involves liaising with various stakeholders, practice building rapport during your interview. Use active listening and engage with your interviewers by asking insightful questions about their experiences and the company culture.
✨Demonstrate Attention to Detail
Prepare to highlight instances where your attention to detail made a difference in your previous roles. Whether it’s tracking performance indicators or preparing reports, showing that you can maintain high standards will resonate well with the interviewers.