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- Tasks: Lead projects in pharmacovigilance, ensuring safety plans and compliance are top-notch.
- Company: Join Clinigen, a fast-growing global pharmaceutical services company with a vibrant culture.
- Benefits: Enjoy competitive pay, diverse opportunities, and a commitment to equal employment.
- Why this job: Make a real difference in patient safety while advancing your career in a dynamic environment.
- Qualifications: Experience in pharmacovigilance and strong communication skills are essential.
- Other info: Be part of a team that values innovation and collaboration across the globe.
The predicted salary is between 36000 - 60000 £ per year.
Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.
Please Note: Candidates without Pharmacovigilance experience need not apply at this time.
Responsibilities- Manage daily interaction with Clients, Sponsors and staff to assist in developing and implementing project-specific safety plans, safety documents, SOPs and guidelines to reflect specific work processes.
- Assist with Safety Management Plan development and safety database configuration and ensure project team is up to date on all relevant changes.
- Ensure that relevant data is entered and maintained in the safety database system in collaboration with the Medical/Safety business unit.
- Ensure Pharmacovigilance files for assigned projects are properly maintained and/or provided to Records Management in a timely manner.
- Manage communications between appropriate team members, Clients, and Sponsors when safety issues are identified.
- Participate in training sessions and workshops, including presenting reports from any conferences attended, as agreed.
- Monitor compliance metrics, project budgets, and service level agreements for assigned projects to ensure regulations and timelines are being met and activities performed are within the approved budget.
- BS Degree (or equivalent work experience).
- Prior experience working in a contract research organization (CRO), pharmaceutical and/or biotech company.
- Broad working knowledge of Clinical and/or Post-marketing PVG and safety reporting requirements under the FDA/International regulations, ICH/GCP guidelines and other relevant requirements.
- Effective communicator (written and oral); concise, accurate and business appropriate.
- Excellent attention to detail and effective organization.
- Demonstrated critical thinking and problem-solving skills.
- Ability to manage multiple tasks with deadlines.
- Proven effective collaboration with other functional areas.
- Excellent interpersonal skills.
- Computer literacy in MS Word, Excel and PowerPoint.
- Self-starter, able to work with a high degree of independence.
- Ability to manage multiple projects simultaneously while maintaining a high level of quality.
- Ability to diplomatically address sensitive issues confidentially and professionally.
- Prior experience with regulatory inspections.
- Previous experience of case processing.
- Working knowledge of the ARGUS safety database.
- Computer literacy in Visio and other Project Management tools.
EEO Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.
Senior Project Manager (Pharmacovigilance) employer: Clinigen
Contact Detail:
Clinigen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Project Manager (Pharmacovigilance)
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and biotech industries. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by researching Clinigen and its projects. Understand their approach to pharmacovigilance and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate; you’re genuinely interested in their mission!
✨Tip Number 3
Practice your communication skills! As a Senior Project Manager, you’ll need to convey complex information clearly. Try mock interviews with friends or use online platforms to refine your pitch and ensure you come across as confident and articulate.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the team at Clinigen. Let’s get you that dream job!
We think you need these skills to ace Senior Project Manager (Pharmacovigilance)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in Pharmacovigilance. We want to see how your background aligns with the specific requirements of the Senior Project Manager role, so don’t hold back on showcasing relevant projects and achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for Clinigen. We love seeing enthusiasm and a clear understanding of our business, so let your personality come through while keeping it professional.
Showcase Your Communication Skills: As an effective communicator, it’s crucial to demonstrate this in your application. Use clear and concise language, and make sure there are no typos or errors. We appreciate attention to detail, so take the time to proofread your application before hitting send!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there, which can help you tailor your application even further!
How to prepare for a job interview at Clinigen
✨Know Your Pharmacovigilance Inside Out
Make sure you brush up on your knowledge of pharmacovigilance and safety reporting requirements. Be ready to discuss specific regulations, ICH/GCP guidelines, and how they apply to the role. This will show that you’re not just familiar with the terms but can also apply them in real-world scenarios.
✨Showcase Your Project Management Skills
Prepare examples from your past experiences where you successfully managed multiple projects or tasks simultaneously. Highlight your ability to meet deadlines while maintaining quality. Use the STAR method (Situation, Task, Action, Result) to structure your responses for clarity.
✨Communicate Effectively
Since effective communication is key in this role, practice articulating your thoughts clearly and concisely. Think about how you would explain complex safety issues to clients or team members. You might even want to prepare a few questions to ask during the interview to demonstrate your engagement.
✨Be Ready for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to handle sensitive issues. Prepare by thinking through potential challenges you might face in the role and how you would address them. This will help you showcase your critical thinking abilities and professionalism.
