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For Companies At a Glance
- Tasks: Join our safety team to manage and analyze safety data for regulatory compliance.
- Company: Be part of a global pharmaceutical group dedicated to innovative healthcare solutions.
- Benefits: Enjoy competitive salary, remote work options, and the chance to impact patient lives.
- Why this job: Gain hands-on experience in pharmacovigilance while working with top scientific experts.
- Qualifications: Life science degree and 3 years in pharmacovigilance required; attention to detail is key.
- Other info: Opportunity for international travel and collaboration in a fast-growing company.
The predicted salary is between 36000 - 60000 £ per year.
POSITION DETAILS
Title: Pharmacovigilance Data Associate
Upward Reporting: Head of Quality and Drug Safety
Position Type: Permanent, ongoing with a 6-month probation period
Location: London, UK
Hours: Regular working hours are Monday to Friday from 9.00am to 5.30pm, with two days office attendance and three days remote working.
Travel: Some international travel may be required
ABOUT THE COMPANY
A global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.
DESCRIPTION OF THE ROLE
- Assist the safety team in handling safety data (including adverse events) in compliance with regulatory requirements and Company SOPs
- Case processing
- MedDRA coding of safety events to the current version as required
- Data entry in the Pharmacovigilance Database
- Maintain the Pharmacovigilance Database
- Monitoring adverse events (AEs) arriving via EEDR
- Produce safety data, in the required format for signal detection and for inclusion in periodic aggregate reports
- Provide safety data, in the required format, to the regulatory department for submission to the regulatory authorities
- Assist in the ongoing improvement of the pharmacovigilance system
- ICSR and SUSAR reporting via EVWEB (upon training); Medical and Scientific Literature search
ESSENTIAL REQUIREMENTS FOR ROLE
- Life science degree
- Working knowledge of GVP guidelines
- Working knowledge of ICH GCP guidelines
- At least 3 years’ experience in pharmacovigilance compliance/quality fields
- Excellent attention to detail
- High level of computer literacy
- Ability to plan, organise and follow up
- Track and plan clinical activities to meet agreed timelines
- Maintain a current awareness of pharmacovigilance requirements
- Effective verbal and written communication in individual and group settings
- Ability to create and maintain relationships with internal/external customers
- Ability to work in a team environment
- Problem-solving skills
- Effective time management of multiple tasks
- Inquisitive mind
- European languages an advantage (German/Italian/French)
WHAT’S ON OFFER:
- A competitive salary with benefits.
- The chance to contribute and be part of a team whose work directly benefits healthcare and strives to improve people’s lives.
- A real hands-on opportunity to gain a high degree of commercial exposure.
- The chance to work alongside world-leading scientific experts.
- Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.
Pharmacovigilance Data Associate employer: EPM Scientific
Contact Detail:
EPM Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Data Associate
✨Tip Number 1
Familiarize yourself with the latest GVP and ICH GCP guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the pharmacovigilance field.
✨Tip Number 2
Highlight any experience you have with MedDRA coding and data entry in pharmacovigilance databases. Be prepared to discuss specific examples of how you've handled safety data in compliance with regulatory requirements.
✨Tip Number 3
Showcase your problem-solving skills by preparing examples of challenges you've faced in previous roles and how you overcame them. This will illustrate your ability to handle the complexities of pharmacovigilance.
✨Tip Number 4
If you speak any European languages, especially German, Italian, or French, make sure to mention this during your discussions. It can set you apart from other candidates and is a valuable asset for international travel.
We think you need these skills to ace Pharmacovigilance Data Associate
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Pharmacovigilance Data Associate position. Highlight key responsibilities and essential requirements that align with your experience.
Tailor Your CV: Customize your CV to emphasize your relevant experience in pharmacovigilance, compliance, and quality fields. Include specific examples of your work with safety data and any familiarity with GVP and ICH GCP guidelines.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for pharmacovigilance and your understanding of the company's mission. Mention how your skills and experiences make you a great fit for the role and how you can contribute to the team.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. Ensure that your documents are clear, concise, and professional, reflecting your attention to detail.
How to prepare for a job interview at EPM Scientific
✨Show Your Knowledge of Pharmacovigilance
Make sure to brush up on your understanding of GVP and ICH GCP guidelines. Being able to discuss these in detail will demonstrate your expertise and commitment to compliance, which is crucial for the role.
✨Highlight Your Attention to Detail
Since this position requires excellent attention to detail, prepare examples from your past experience where your meticulousness made a difference. This could be related to data entry or case processing.
✨Demonstrate Teamwork Skills
Be ready to share experiences that showcase your ability to work effectively in a team environment. Highlight how you’ve collaborated with others to achieve common goals, especially in high-pressure situations.
✨Prepare for Technical Questions
Expect questions related to pharmacovigilance databases and signal detection processes. Familiarize yourself with the tools and systems mentioned in the job description, such as EVWEB, to show your readiness for the role.
