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- Tasks: Manage case safety reports and ensure compliance with safety regulations.
- Company: ProPharma enhances health by supporting biotech and pharmaceutical innovations.
- Benefits: Enjoy remote work flexibility and a supportive, inclusive culture.
- Why this job: Join a team dedicated to improving patient safety and making a real impact.
- Qualifications: Bachelor's in life sciences required; two years of related experience preferred.
- Other info: This is a 12-month fixed-term position with opportunities for growth.
The predicted salary is between 30000 - 42000 £ per year.
Job Location: London, UK
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Entry level
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.
The Pharmacovigilance (PV) Specialist, Case Processing manages individual case safety reports, performs initial case-level assessment of expectedness, confirms seriousness, composes accurate and thorough medical narratives, and generates queries for missing or unclear information. The PV Specialist ensures all cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines, Working Practices, SOPs, and applicable safety regulations. The PV Specialist maintains distinctive quality and commitment as the operating philosophy in carrying out all processes, and continually seeks out ways to enhance customer service experience both internally and externally.
Please note this is for a 12 month Fixed term position.
Essential Functions- Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.
- Perform case follow up activities such as identification of information to be collected during follow-up.
- Creating and reviewing case narratives.
- Providing client notifications as required for case management.
- Supporting and contributing to the development of training materials and training delivery.
- Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs.
- Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
- Peer reviews of cases for quality, consistency, and accuracy as needed.
- Other duties as assigned.
- Strong verbal, written and interpersonal communication skills.
- High level of accuracy and attention to detail.
- Ability to identify and resolve problems in a timely manner.
- Able to work independently and collaboratively in a multi-disciplinary team.
- Excellent organization and prioritization skills; able to multitask.
- Basic knowledge of Pharmacovigilance.
- Required: a Bachelor's degree in life sciences.
- Preferred: advanced degree, RN, RPh, PharmD or equivalent.
- Two years of related work experience.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
Pharmacovigilance Specialist, Case Processing - 12 month Fixed term - remote employer: Lifelancer
Contact Detail:
Lifelancer Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Specialist, Case Processing - 12 month Fixed term - remote
✨Tip Number 1
Familiarise yourself with MedDRA coding and pharmacovigilance regulations. Understanding these key areas will not only help you in the role but also demonstrate your commitment and knowledge during interviews.
✨Tip Number 2
Network with professionals in the pharmacovigilance field. Join relevant online forums or LinkedIn groups to connect with others, share insights, and learn about industry trends that could give you an edge.
✨Tip Number 3
Prepare for potential case study scenarios that may be presented during interviews. Practising how you would handle specific adverse event cases can showcase your problem-solving skills and attention to detail.
✨Tip Number 4
Stay updated on recent developments in drug safety and pharmacovigilance. Being knowledgeable about current events and changes in regulations can impress interviewers and show your proactive approach to the field.
We think you need these skills to ace Pharmacovigilance Specialist, Case Processing - 12 month Fixed term - remote
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Pharmacovigilance Specialist. Familiarise yourself with case processing, adverse event reporting, and the importance of regulatory compliance.
Tailor Your CV: Highlight relevant experience in pharmacovigilance or related fields. Emphasise your attention to detail, communication skills, and any specific knowledge of safety regulations that align with the job description.
Craft a Compelling Cover Letter: Use your cover letter to explain why you're passionate about pharmacovigilance and how your background makes you a suitable candidate. Mention any specific experiences that demonstrate your ability to handle case processing and regulatory requirements.
Proofread Your Application: Ensure your application is free from spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial for the role of a Pharmacovigilance Specialist.
How to prepare for a job interview at Lifelancer
✨Know Your Pharmacovigilance Basics
Make sure you brush up on your knowledge of pharmacovigilance principles, especially case processing and reporting. Be prepared to discuss how you would handle adverse event cases and the importance of accuracy in this field.
✨Demonstrate Attention to Detail
Since this role requires a high level of accuracy, be ready to provide examples from your past experiences where your attention to detail made a significant impact. Highlight any specific tools or methods you use to ensure quality in your work.
✨Showcase Your Communication Skills
Strong verbal and written communication skills are essential for this position. Prepare to discuss how you effectively communicate complex information, both in writing and verbally, and consider sharing examples of how you've collaborated with teams in the past.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities. Think about potential challenges you might face in case processing and how you would approach resolving them. This will demonstrate your critical thinking and adaptability.
