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- Tasks: Lead pharmacovigilance processes, ensuring compliance and safety in drug development.
- Company: Join a global specialty pharmaceutical group dedicated to innovative healthcare solutions.
- Benefits: Enjoy competitive salary, remote work flexibility, and hands-on experience with experts.
- Why this job: Make a real impact on patient safety while working in a dynamic, fast-growing environment.
- Qualifications: Bachelor's degree in science; strong pharmacovigilance background required.
- Other info: Opportunity for international travel and collaboration with top scientific minds.
The predicted salary is between 48000 - 72000 £ per year.
POSITION DETAILS
Title: Pharmacovigilance Manager
Upward Reporting: Head of Quality and Drug Safety
Position Type: Permanent, ongoing with a 6-month probation period
Location: Egham, 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
- Responsible for all processes and operating procedures to ensure compliance with appropriate regulations and quality standards
- Work with the Head of Quality and Drug Safety and the EU QPPV to identify gaps with current processes, handle management escalation, as well as identifying possible resolutions
- Develop & manage Standard Operating Procedures
- Oversee case management and case handling, including providing back-up support for case handling staff where needed
- Oversee safety database management
- Oversee signal detection and risk management
- Review and approve Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs)
- Review and manage updates to Risk Management Plans, including liaising with clinical colleagues on post-marketing activities worldwide
- PSMF maintenance & update
- Internal training of staff where necessary
- Establish key performance metrics to measure compliance and data quality
- Preparation with relevant teams for any internal audits or regulatory inspections
- Serve as the pharmacovigilance subject matter expert for internal audits and regulatory inspections
- Responsible for management of external pharmacovigilance service providers (i.e., national responsible/representatives)
- Develop Safety Data Exchange Agreements with Contract Organisations
ESSENTIAL REQUIREMENTS FOR ROLE
- Bachelor’s degree or equivalent experience in science; Masters or PhD in pharmacy, biological science or related field
- Experienced professional with a strong background in pharmacovigilance who is passionate about safety in drug development/post-marketing
- Proven track record in pharmacovigilance; extensive experience in CRO or pharmaceutical industry
- Excellent communication skills, both written and verbal
- Project management skills
- Independence and the ability to lead a team effectively
- Observational and analytical skills
- Good time management and the ability to work to tight deadlines
- Ability to problem solve and make decisions quickly
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 Manager employer: EPM Scientific
Contact Detail:
EPM Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Manager
✨Tip Number 1
Familiarize yourself with the latest regulations and quality standards in pharmacovigilance. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during discussions.
✨Tip Number 2
Network with professionals in the pharmacovigilance field, especially those who have experience in CROs or pharmaceutical companies. Engaging with them can provide insights into the industry and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed safety data and handled case management in your previous roles. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Stay updated on current trends and challenges in drug safety and pharmacovigilance. Being knowledgeable about recent developments will show your passion for the field and your readiness to contribute effectively.
We think you need these skills to ace Pharmacovigilance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in pharmacovigilance, including any specific projects or roles that demonstrate your expertise in safety management and compliance with regulations.
Craft a Strong Cover Letter: Write a cover letter that clearly outlines your passion for drug safety and your understanding of the pharmacovigilance processes. Mention how your background aligns with the responsibilities listed in the job description.
Highlight Key Skills: In your application, emphasize your project management skills, communication abilities, and analytical capabilities. Provide examples of how you've successfully led teams or managed projects in the past.
Prepare for Interviews: If selected for an interview, be ready to discuss your previous experiences in detail, particularly those related to case management, signal detection, and regulatory compliance. Prepare questions that show your interest in the company's mission and values.
How to prepare for a job interview at EPM Scientific
✨Show Your Passion for Pharmacovigilance
Make sure to express your enthusiasm for drug safety and pharmacovigilance during the interview. Share specific examples from your past experiences that highlight your commitment to ensuring patient safety and compliance with regulations.
✨Demonstrate Your Analytical Skills
Prepare to discuss how you've used your observational and analytical skills in previous roles. Be ready to provide examples of how you identified gaps in processes and implemented solutions, as this is crucial for the role.
✨Highlight Your Project Management Experience
Since project management is a key requirement, be prepared to talk about your experience managing projects, especially in pharmacovigilance. Discuss how you prioritize tasks, manage deadlines, and lead teams effectively.
✨Prepare for Regulatory Questions
Expect questions related to regulatory compliance and internal audits. Brush up on your knowledge of relevant regulations and be ready to discuss how you've handled audits or inspections in the past.
