At a Glance
- Tasks: Review and approve safety reports, assess medical issues, and support risk management.
- Company: Global pharmaceutical company focused on safety and innovation.
- Benefits: Career development, supportive environment, and international collaboration.
- Other info: Dynamic role with opportunities for personal and professional growth.
- Why this job: Make a real impact in patient safety while working with a diverse team.
- Qualifications: Medically qualified physician with pharmacovigilance experience and strong language skills.
The predicted salary is between 60000 - 80000 € per year.
Contract Department: PV Medical Group
Responsibilities
- To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes 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 any safety issues.
- To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy.
- To review articles to determine if they contain ICSSRs/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 required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation.
- Evaluating and categorising 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.
- English - advanced (spoken, written).
- Japanese - advanced (spoken, written).
- Advanced literacy (MS Office).
Benefits
- 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.
Pharmacovigilance Physician I / II - Fluent in Japanese - 1 year fixed term contract employer: Prime Vigilance Ltd
Join a leading organisation that prioritises your professional growth and offers a supportive, friendly work environment. As a Pharmacovigilance Physician in our dynamic team, you will have the opportunity to collaborate with colleagues globally while enhancing your skills through comprehensive training and development programmes. Our commitment to fostering a culture of teamwork and personal development makes us an exceptional employer for those seeking meaningful and rewarding careers.
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. Be ready to discuss your experience and how it relates to the role. We want to see your passion for pharmacovigilance!
✨Tip Number 3
Show off your language skills! Since fluency in Japanese is key, practice discussing pharmacovigilance topics in both English and Japanese. This will help you stand out during interviews.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect with us directly.
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 highlight your experience in pharmacovigilance and any relevant qualifications. We want to see how your skills match the job description, so don’t hold back on showcasing your expertise!
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 the role. Keep it engaging and personal – we love to see your personality come through.
Showcase Your Language Skills:Since fluency in Japanese is a must, make sure to highlight your language skills prominently. Whether it’s in your CV or cover letter, let us know how you’ve used your language abilities in a professional setting.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Prime Vigilance Ltd
✨Know Your Pharmacovigilance Stuff
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 reviewing these reports and how you've contributed to safety assessments.
✨Show Off Your Language Skills
Since fluency in Japanese is a must, practice discussing pharmacovigilance topics in both English and Japanese. You might be asked to explain complex concepts in either language, so being comfortable switching between them will impress your interviewers.
✨Demonstrate Teamwork and Communication
Highlight your interpersonal skills and ability to work cross-culturally. Share examples of how you've successfully collaborated with diverse teams in the past, as this role requires effective communication across different functions and cultures.
✨Prepare for Signal Detection Questions
Expect questions about signal detection activities and benefit-risk assessments. Brush up on your knowledge of risk management plans and be prepared to discuss how you've evaluated and categorised signals in your previous roles.
