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- Tasks: Manage pharmacovigilance activities and ensure compliance with regulatory requirements.
- Company: Join a leading company in the pharmaceutical industry with a focus on safety.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real difference in patient safety while working in a dynamic environment.
- Qualifications: Experience in pharmacovigilance and strong attention to detail required.
- Other info: Collaborative team culture with opportunities for career advancement.
The predicted salary is between 36000 - 60000 £ per year.
Experienced Pharmacovigilance Officer (Hybrid role). This is NOT an entry level role. 3 month initial Fixed Term Contract. Immediate start preferred.
The Pharmacovigilance Officer has responsibility for the conduct and delivery of Pharmacovigilance activities on assigned projects, management and oversight of incoming information, as well as input to the development and maintenance of TMC PV systems. Integral to the PV department’s day-to-day operational tasks, the PV Officer will be responsible for a variety of pharmacovigilance activities. These will include safety database administration, PV case processing related work, such as the triage and data entry of incoming PV information (e.g. processing individual case safety reports – ICSRs), management of PV eTMF filing, communication with clients on key deliverables (project dependent). The PV officer will need to comply with the applicable regulatory requirements (e.g. GVP) as well as work to TMC’s SOPs, both in relation to clinical trials and with marketed products.
THIS IS A HYBRID ROLE: we expect the successful candidate to be able to come to the office in Hartley Wintney, Hampshire, regularly.
Role-specific tasks include:
- Maintenance of SAE/SUSAR/AESI trackers
- Argus safety database administration
- ICSR case processing including triage, data entry, quality control and submission
- Issuing and tracking ICSR queries
- Working with PV physician to co-ordinate medical review of cases and drafting of analysis of similar events (AOSEs) as required
- Coding Adverse Events and the medicines/treatments recorded on the Adverse Drug Reaction and Serious Adverse Event reports, according to MedDRA & WHODrug standards
- Supporting SAE reconciliation with clinical databases and eTMF filing, as required
- Liaising with the Sponsor / MA Holder on expediting Adverse Event reports as required
- Organising and minuting TMC project team meetings
- Building and maintaining good relationships across all TMC functional units
- Provide input and support to TMC to ensure compliance (including monitoring of departmental metrics) with current PV regulatory requirements
- Supporting PV audit and inspection activities, as required
- Other duties as assigned by management (e.g. supporting signal detection activities, PSMF updates etc.)
Pharmacovigilance Officer in Hook employer: T M C Pharma Services Ltd
Contact Detail:
T M C Pharma Services Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Officer in Hook
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GVP and TMC’s SOPs. We recommend practising common interview questions related to pharmacovigilance activities so you can showcase your expertise and confidence when it counts.
✨Tip Number 3
Don’t forget to follow up after your interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We suggest mentioning something specific from your conversation to make it more personal.
✨Tip Number 4
Apply through our website for the best chance of getting noticed! We’re always on the lookout for passionate candidates who are ready to dive into the world of pharmacovigilance. Let’s get you started on this exciting journey!
We think you need these skills to ace Pharmacovigilance Officer in Hook
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Pharmacovigilance Officer role. Highlight relevant experience and skills that match the job description, especially in safety database administration and case processing.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this hybrid role. Share specific examples of your past work in pharmacovigilance and how you’ve contributed to compliance and operational tasks.
Showcase Your Attention to Detail: Since this role involves a lot of data entry and quality control, make sure to demonstrate your attention to detail in your application. Mention any relevant experiences where accuracy was key to your success.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and get you started on your journey with StudySmarter!
How to prepare for a job interview at T M C Pharma Services Ltd
✨Know Your Pharmacovigilance Basics
Make sure you brush up on your pharmacovigilance knowledge, especially around safety database administration and ICSR case processing. Familiarise yourself with GVP regulations and TMC's SOPs, as these will likely come up during the interview.
✨Showcase Your Experience
Since this isn't an entry-level role, be ready to discuss your previous experience in pharmacovigilance. Prepare specific examples of how you've managed PV activities, handled adverse event reports, or worked with safety databases like Argus.
✨Demonstrate Communication Skills
As a Pharmacovigilance Officer, you'll need to liaise with various stakeholders. Practice articulating how you've effectively communicated with clients or team members in past roles, especially regarding key deliverables and project updates.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think about how you would handle issues like SAE reconciliation or coding adverse events, and be ready to explain your thought process.