At a Glance
- Tasks: Review and approve safety reports, assess medical issues, and support regulatory responses.
- Company: Join PrimeVigilance, a global leader in pharmacovigilance with a focus on employee well-being.
- Benefits: Comprehensive training, career development, and a supportive work environment.
- Other info: Embrace a culture of diversity, equity, and inclusion in a collaborative workplace.
- Why this job: Make a real impact on patient safety while working with a diverse team worldwide.
- Qualifications: Medically qualified physician with pharmacovigilance experience and strong communication skills.
The predicted salary is between 50000 - 60000 € 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.
Pharmacovigilance Physician I / II - Fluent in Japanese - 1 year fixed term contract employer: PrimeVigilance
At PrimeVigilance, we pride ourselves on being an excellent employer that champions diversity, equity, and inclusion within a supportive and collaborative work environment. Our commitment to employee well-being is reflected in our comprehensive training and career development opportunities, allowing you to grow both personally and professionally while making a meaningful impact in the field of pharmacovigilance. Join us and be part of a global team dedicated to improving lives through quality and integrity.
StudySmarter Expert Advice🤫
We think this is how you could land Pharmacovigilance Physician I / II - Fluent in Japanese - 1 year fixed term contract
✨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 open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICSR and SAE reports. Show us you know your stuff, and don’t forget to highlight your experience with signal detection!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or mentors to get comfortable discussing your skills and experiences. The more you practice, the more confident you'll feel.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about joining our team.
We think you need these skills to ace Pharmacovigilance Physician I / II - Fluent in Japanese - 1 year fixed term contract
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Pharmacovigilance Physician role. Highlight your relevant experience in pharmacovigilance, signal detection, and any medical qualifications you have. 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 your background makes you a great fit for our team. Don’t forget to mention your fluency in Japanese – it’s a big plus for us!
Showcase Your Interpersonal Skills:Since this role involves working cross-culturally and collaboratively, make sure to highlight your interpersonal skills. Share examples of how you've successfully worked in teams or communicated effectively with diverse groups in your application.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at PrimeVigilance!
How to prepare for a job interview at PrimeVigilance
✨Know Your Pharmacovigilance Basics
Make sure you brush up on your pharmacovigilance knowledge, especially around Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs). Be ready to discuss your previous experience in these areas and how it relates to the role.
✨Showcase Your Language Skills
Since fluency in Japanese is a must, prepare to demonstrate your language skills during the interview. You might be asked to discuss complex topics in Japanese, so practice articulating your thoughts clearly in both English and Japanese.
✨Highlight Teamwork and Communication
PrimeVigilance values collaboration, so be prepared to share examples of how you've worked effectively in teams. Discuss your interpersonal skills and how you’ve communicated complex information to diverse audiences.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities in pharmacovigilance. Think about past experiences where you had to evaluate safety issues or manage multiple tasks, and be ready to explain your thought process.
