At a Glance
- Tasks: Lead a dynamic team in delivering high-quality medical writing for patient safety.
- Company: Join PrimeVigilance, a global leader in pharmacovigilance dedicated to patient safety.
- Benefits: Enjoy a supportive culture, competitive salary, and opportunities for professional growth.
- Other info: Be part of a diverse team that values integrity, collaboration, and agility.
- Why this job: Make a real impact on patient safety while working with a passionate team.
- Qualifications: Extensive experience in pharmacovigilance and leadership skills required.
The predicted salary is between 80000 - 100000 £ per year.
Company Description
Medicine moves forward here. So will you.
At Prime Vigilance, patient safety is not just one part of the job—it is why we exist.
We are a global pharmacovigilance specialist.
Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post‑marketing surveillance.
Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight that our clients can act on.
That work takes curious minds, problem‑solvers and experts who care about getting it right.
It also requires a culture worth staying for.
Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.
If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.
Job Description
The Senior Director / Executive Director Medical Writing is a senior management position, member of the Senior Leadership Team; acts as Head of PV Medical Writing Group and has primary responsibility to ensure the contracted PV activities are appropriately performed in line with company policies/procedures and in compliance with global regulations.
Responsibilities
- Lead the PV Medical Writing function, ensuring high‑quality, compliant, and timely deliverables.
- Manage and develop the PV Medical Writing team, fostering performance, engagement, and professional growth.
- Drive quality, compliance, inspection readiness, and continuous improvement initiatives, including oversight of SOPs, KPIs, audits and regulatory inspections.
- Provide strategic PV medical writing expertise and subject‑matter leadership to clients, internal stakeholders and project teams.
- Support business development activities, including proposals, bid defenses and client engagements.
- Oversee departmental resources, budgets and operational performance to ensure efficient service delivery.
- Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports and other key pharmacovigilance deliverables.
- Build and maintain strong client relationships, ensuring exceptional service and trusted partnerships.
- Represent the organization externally through industry engagement, publications, presentations and professional development activities.
Qualifications
The preferred candidate will have
- Extensive pharmacovigilance and PV Medical Writing experience, including leadership and people management of high‑performing teams.
- Deep knowledge of global pharmacovigilance regulations, with expertise in authoring and reviewing aggregate safety reports and PV procedures.
- Proven experience supporting regulatory compliance, inspections and pharmacovigilance system oversight, including QPPV or Deputy QPPV responsibilities.
- Strong business acumen with experience supporting proposals, client engagements and bid defense activities.
- Excellent scientific, regulatory and analytical capabilities, including translating complex clinical and safety data into clear, high‑quality regulatory and scientific documents.
- Additional Information
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.
You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance and quality consulting.
We are diverse in many ways, yet our values unite us. The values are how we work, not words on a wall. If they resonate with you, you will feel at home here.
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.
#J-18808-Ljbffr
Senior Director / Executive Director Medical Writing in Guildford employer: PrimeVigilance
As a PV Officer, Team Lead, you will thrive in a dynamic and supportive environment that prioritises personal and professional growth. Our company offers extensive training and development opportunities, fostering a culture of collaboration with colleagues from around the globe, all while ensuring effective ICSR management. Join us to make a meaningful impact in pharmacovigilance while enjoying a friendly workplace that values your contributions.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Director / Executive Director Medical Writing in Guildford
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like PrimeVigilance. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like PrimeVigilance.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like PrimeVigilance. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what PrimeVigilance is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Director / Executive Director Medical Writing in Guildford
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at PrimeVigilance!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show PrimeVigilance that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at PrimeVigilance!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At PrimeVigilance, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at PrimeVigilance
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at PrimeVigilance that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with PrimeVigilance’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
