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- Tasks: Review and approve safety reports, ensuring patient well-being in clinical trials.
- Company: Join PrimeVigilance, a global leader in pharmacovigilance with a supportive culture.
- Benefits: Comprehensive training, career development, and a friendly work environment.
- Other info: Emphasises diversity, equity, and inclusion in a collaborative workplace.
- Why this job: Make a real impact on patient safety while working with a diverse team.
- Qualifications: Medically qualified physician with pharmacovigilance experience and strong communication skills.
The predicted salary is between 40000 - 50000 £ per year.
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We operate globally with staff across Europe, North America and Asia, covering Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides support to pharmaceutical and biotechnology partners and aims to invest in staff through comprehensive training and development, with a focus on employee well-being and work-life balance.
For the Client:
- To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports in clinical trials for medical/causality assessment, including coding, seriousness assessment, company causality and comment, listedness/expectedness and follow-up questions.
- To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of safety issues.
- To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports and literature screening strategy.
- To review articles to determine if they contain ICSRs/SAEs related to the relevant medicinal product or other safety-related findings.
- To cooperate in the preparation of and provide input in Risk Management Plans.
- Supporting the preparation of responses to regulatory authority requests.
- Signalling.
- Reviewing line listings.
- Participating in signal detection activities including meetings, writing signal detection reports if applicable, and providing consultation to clients on benefit/risk assessment and risk minimisation.
- Evaluating and categorizing possible signals and proposing a course of action.
- Supporting preparation and review of benefit-risk reports.
Qualifications
- The PV Physician should be medically qualified as a physician.
- Previous experience in pharmacovigilance.
- Ability to review different aggregate report types including PBRERs and DSURs.
- Expertise in signal detection activities is essential.
- Excellent interpersonal skills.
- Ability to plan, organise, prioritise and execute multiple tasks.
- Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork.
- Strong communication and presentation skills.
- English - advanced (spoken, written); Japanese - advanced (spoken, written).
- Advanced literacy in MS Office.
Why PrimeVigilance
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human-first approach, recognizing that our people are our greatest strength in improving lives.
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 central to how we operate. If they resonate with you, PrimeVigilance could be a great company to join:
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
Come and join us in this exciting journey to make a positive impact in patients’ lives. We look forward to welcoming your application.
PV Physician I / II - Fluent in Japanese - 1 year fixed term contract in London employer: PrimeVigilance
Contact Detail:
PrimeVigilance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land PV Physician I / II - Fluent in Japanese - 1 year fixed term contract in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of pharmacovigilance and recent safety regulations. We want you to shine, so practice common interview questions and have your own ready to ask!
✨Tip Number 3
Show off your language skills! Since this role requires fluency in Japanese, be sure to highlight your language abilities during interviews. It’s a big plus that sets you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace PV Physician I / II - Fluent in Japanese - 1 year fixed term contract in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of PV Physician. Highlight your pharmacovigilance experience and any relevant qualifications. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about pharmacovigilance and how you can contribute to our team. Keep it concise but impactful – we love a good story!
Show Off Your Language Skills: Since fluency in Japanese is a must, make sure to showcase your language skills clearly in your application. If you've worked in bilingual environments before, let us know – it could set you apart!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets to us quickly and efficiently. Plus, it shows you're keen on joining our team!
How to prepare for a job interview at PrimeVigilance
✨Know Your Stuff
Make sure you brush up on pharmacovigilance concepts and the specific responsibilities of a PV Physician. Familiarise yourself with Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports, as well as the latest trends in signal detection. This will show your genuine interest and expertise during the interview.
✨Showcase Your Language Skills
Since fluency in Japanese is a must, be prepared to demonstrate your language skills. You might be asked to discuss complex medical topics in Japanese, so practice articulating your thoughts clearly in both English and Japanese. This will highlight your ability to communicate effectively across cultures.
✨Highlight Teamwork Experience
PrimeVigilance values collaboration, so come ready to share examples of how you've successfully worked in teams. Discuss any cross-functional projects you've been involved in and how you contributed to achieving common goals. This will resonate well with their emphasis on teamwork.
✨Prepare Questions
Interviews are a two-way street, so prepare thoughtful questions about the company culture, training opportunities, and how they support employee well-being. This shows that you're not just interested in the role, but also in how you can grow within the company.