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- Tasks: Process Individual Case Safety Reports and ensure data integrity in pharmacovigilance.
- Company: Join Hemofarm, part of STADA Group, a leading global pharmaceutical company.
- Benefits: Enjoy private healthcare, professional development, and mental health support.
- Why this job: Make a real impact in global health while developing your skills.
- Qualifications: Degree in pharmacy, medicine, or natural sciences; strong communication skills required.
- Other info: Dynamic work environment with opportunities for language learning and career growth.
The predicted salary is between 36000 - 60000 £ per year.
Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.
About the role:
As a Global ICSR (Individual Case Safety Report Management) Specialist, you will be responsible for processing Individual Case Safety Reports (ICSRs) from various global sources, maintaining data integrity, and assisting in the regulatory compliance of pharmacovigilance activities.
Responsibilities:
- Processing of Individual Case Safety Reports (ICSRs) related to STADA medicinal products from sources worldwide (spontaneous reports, studies, literature, competent authorities, and contractual partners).
- Data entry into the global Pharmacovigilance (PV) database.
- Checking for duplicates in the database.
- Writing narratives for the reports.
- MedDRA coding (Medical Dictionary for Regulatory Activities coding).
- Archiving of reports and documentation.
- Medical and pharmacological assessment of adverse drug reactions (ADRs).
- Quality control of data entry performed by Local Pharmacovigilance Units (LPUs) of STADA affiliates.
- Submission of ICSR to competent authorities, the European Medicines Agency (EMA), LPUs, and contractual partners, along with timeline surveillance of ICSR reporting.
- Writing working instructions (Standard Operating Procedures (SOPs) and Operational Procedures (OPs)) and providing support to LPUs in terms of ICSR processing.
Qualifications:
- University degree in pharmacy, human medicine or natural sciences.
- Good communication skills.
- Fluent in English (orally and in writing).
- Responsible, careful and independent work.
- Structured, result-oriented work style.
- Very good software skills (MS-Office, databases).
We offer:
- Private healthcare insurance (with the option of privileged usage for family members).
- Ongoing professional development through specialized education and training.
- A platform for learning 14 foreign languages, using various learning styles, including conversation courses.
- Personalized mental health and well-being support for employees and their families through the Kyan Health app.
Only shortlisted candidates will be contacted.
Global ICSR (Individual Case Safety Report Management) Specialist employer: Hemofarm A.D.
Contact Detail:
Hemofarm A.D. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global ICSR (Individual Case Safety Report Management) Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand Hemofarm's values and how they align with your own. This will help you stand out and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice common interview questions and scenarios related to pharmacovigilance. Being able to articulate your experience with ICSR processing and data integrity will give you a leg up during the interview.
✨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, it shows you’re serious about joining the Hemofarm family.
We think you need these skills to ace Global ICSR (Individual Case Safety Report Management) Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Global ICSR Specialist role. Highlight relevant experience in pharmacovigilance and any specific skills that match the job description. We want to see how you fit into our world!
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 values align with ours at Hemofarm. Keep it engaging and personal – we love a good story!
Showcase Your Skills: Don’t forget to mention your software skills and any experience with databases or data entry. We’re looking for someone who can hit the ground running, so let us know what you bring to the table!
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 Hemofarm A.D.
✨Know Your ICSR Inside Out
Make sure you understand the ins and outs of Individual Case Safety Reports. Brush up on the key responsibilities listed in the job description, especially around data integrity and regulatory compliance. Being able to discuss specific examples or scenarios will show your expertise and enthusiasm for the role.
✨Showcase Your Communication Skills
As a Global ICSR Specialist, communication is key. Prepare to demonstrate your ability to convey complex information clearly. You might be asked to explain how you would write narratives for reports or interact with local pharmacovigilance units, so think of examples where you've successfully communicated in a professional setting.
✨Familiarise Yourself with MedDRA Coding
Since MedDRA coding is part of the role, it’s crucial to have a basic understanding of it. If you’re not already familiar, do some quick research or take a short online course. Being able to discuss how you would approach coding during the interview can set you apart from other candidates.
✨Prepare Questions About Company Values
Hemofarm values agility, integrity, entrepreneurship, and teamwork. Think of questions that reflect your understanding of these values and how they align with your work style. This shows that you’re not just interested in the job, but also in being a good cultural fit for the company.
