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- Tasks: Join our team to ensure quality in safety report processing and lead pharmacovigilance projects.
- Company: Simbec-Orion is a dynamic CRO focused on improving patients' lives through innovative clinical solutions.
- Benefits: Enjoy flexible work options, mentorship opportunities, and a collaborative environment.
- Why this job: Make a real impact in healthcare while developing your skills in a supportive culture.
- Qualifications: BSc in Life Sciences required; experience in pharmacovigilance and project management preferred.
- Other info: Opportunity to mentor new employees and participate in audits and SOP generation.
The predicted salary is between 36000 - 60000 £ per year.
Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.
We are looking for a Senior Pharmacovigilance Executive to join our Pharmacovigilance team where you will ensure quality in Individual Case Safety Report (ICSR) processing and timely submission of Expedited Safety Reports (ESRs) to the regulatory authorities. You will develop into the role of PV Project Lead on a range of studies/projects and ensure deliverables are maintained to high standards and in line with the contractual agreement. You will carry out PV tasks on other studies/projects and will be involved in mentoring PV Executives. You will work with the Senior PV Manager and Head of PV to address any project concerns and assist the management team during audits and Standard Operating Procedure (SOP)/Work Instructions (WI) generation.
KEY ACCOUNTABILITIES
- Perform ICSR processing and specifically Quality Check of ICSRs from all sources and ensure high quality of case data.
- Prepare and perform submission of ESRs to regulatory authorities as per the regulatory timelines via EudraVigilance or other channels.
- Act as a PV Project Lead on post-box/partial service PV projects and ensure high-quality project deliverables and compliance.
- Liaise with clients and other internal departments to address any concerns/issues and work diligently until resolution.
- Support the PV Lead in pharmacovigilance activities.
- Identify process deviations and prepare CAPA files in a timely manner.
- Support with a client or regulatory authority audits/inspections.
- Assists with generation and review of SOPs and WIs.
- Train and mentor new employees, as required.
- Attend project and internal meetings.
SKILLS REQUIRED
ESSENTIAL
- BSc Life Sciences Degree or equivalent.
- Demonstrated experience in developmental and/or post-marketing pharmacovigilance.
- Previous experience with ICSR processing, QC, and compliance.
- Previous experience with ESR submission QC and compliance.
- Previous experience in a Clinical Research Organisation (CRO).
- Previous experience in pharmacovigilance Project Management of small studies.
DESIRABLE
- MSc Life Sciences or equivalent.
- PhD in Life Sciences or equivalent.
- Pharmacy degree or equivalent.
- Experience in Business Development activities.
WHY YOU SHOULD JOIN US
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.
Senior Pharmacovigilance Executive employer: Simbec-Orion Group
Contact Detail:
Simbec-Orion Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Pharmacovigilance Executive
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines in pharmacovigilance. Understanding the nuances of ICSR processing and ESR submission will not only boost your confidence but also demonstrate your commitment to quality and compliance during interviews.
✨Tip Number 2
Network with professionals in the pharmacovigilance field. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends. This can provide you with valuable insights and may even lead to referrals for job openings.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that highlight your skills in project management and quality assurance. Being able to articulate how you've successfully led projects or mentored others will set you apart as a candidate.
✨Tip Number 4
Research Simbec-Orion's recent projects and achievements in pharmacovigilance. Showing that you understand their work and values during your conversations can help you make a strong impression and align your goals with theirs.
We think you need these skills to ace Senior Pharmacovigilance Executive
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in pharmacovigilance, particularly in ICSR processing and ESR submission. Use specific examples to demonstrate your skills and achievements in these areas.
Craft a Compelling Cover Letter: Write a cover letter that reflects your passion for improving patients' lives and aligns with the company's mission. Mention your experience in project management and how you can contribute to their pharmacovigilance team.
Highlight Relevant Qualifications: Clearly state your educational background, especially if you have a BSc, MSc, or PhD in Life Sciences. Include any certifications or training related to pharmacovigilance that would make you stand out.
Showcase Soft Skills: In addition to technical skills, emphasise your ability to mentor others, communicate effectively with clients, and resolve issues. These soft skills are crucial for the role and should be evident in your application.
How to prepare for a job interview at Simbec-Orion Group
✨Showcase Your Pharmacovigilance Knowledge
Make sure to brush up on your pharmacovigilance principles, especially around ICSR processing and ESR submissions. Be prepared to discuss your previous experiences in detail, highlighting how you've ensured compliance and quality in your past roles.
✨Demonstrate Leadership Skills
As a Senior Pharmacovigilance Executive, you'll be expected to lead projects and mentor others. Share examples of how you've successfully led teams or projects in the past, and how you approach mentoring new employees.
✨Prepare for Regulatory Questions
Since the role involves liaising with regulatory authorities, be ready to answer questions about your experience with audits and inspections. Familiarise yourself with relevant regulations and be prepared to discuss how you've navigated compliance challenges.
✨Highlight Your Problem-Solving Abilities
The job requires addressing project concerns and resolving issues. Think of specific instances where you've identified process deviations and implemented corrective actions. This will demonstrate your proactive approach and ability to maintain high standards.
