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- Tasks: Support Pharmacovigilance Operations and manage ICSR documentation in a remote role.
- Company: Join Alphanumeric, a leader in the pharmaceutical industry, working with top global brands.
- Benefits: Enjoy a competitive salary and the flexibility of 100% remote work from anywhere in the UK.
- Why this job: Be part of a dynamic team driving quality in healthcare while enhancing your skills in a global environment.
- Qualifications: Degree in life sciences or relevant experience; knowledge of pharmacovigilance systems is a plus.
- Other info: This is a 9-month contract with potential for extension; immediate start available.
The predicted salary is between 36000 - 60000 £ per year.
Overview:
Alphanumeric is seeking a Pharmacovigilance Senior Specialist (100% remote) based in the UK for project-based contract work. This project is for one of the biggest pharmaceutical brands in the world.
Job Purpose:
The key purpose of this role is to support Pharmacovigilance Operations “PV Ops”– ICSR Management.
Job conditions:
Start date: ASAP.
Type of contract: 9-month temporary contract (with possibility of extension).
Location: 100% remote in the UK as per client request. The leadership team is based in London.
Working shift: business hours in London – some flexibility is well appreciated thanks to the global nature of our company.
Competitive salary
Please note that we cannot offer work visa sponsorships for this role. In the case of non-resident candidates, we will ask for proof of eligibility to work in the UK.
Key Responsibilities:
- Contribute to creation, maintenance, and archiving of written standards for ICSR Management Team.
- Work across a complex matrix environment to drive high-quality documentation of all processes and procedures to comply with internal standards and external regulatory requirements; where problems or issues are identified, assist in facilitating investigation into root cause and create corrective/preventative actions (CAPAs).
- Escalate identified problems or issues to the appropriate Management Personnel with PV Operations.
- Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
- Work with third parties/vendors to assist in development and implementation of robust processes to support quality-driven organization and in agreement with ICSR Management Team written standards.
- Support Technical Associates with enhancement of knowledge and skills for ICSR Management activities.
- Acts as a global PV Operations subject matter expert for process discussions, including queries on strategy/policy related decisions; authors or provides significant input into the development of written standards.
- Generates new ideas and proposals for global implementation; contributes to advancement of ICSR management
- Prioritize work and time management, in line with business needs
Education Requirements:
Degree in life sciences or medically related field or previous experience equating to educational requirements.
Job Related Experience:
- Process development and maintenance of written standards, e.g. SOPs, Work Instructions, Job Aids, How To Guides, etc.
- Ability to map processes and author written standards.
- Knowledge and experience with pharmacovigilance systems.
Pharmacovigilance Senior Specialist (SME) - 100% Remote (based in the UK) employer: Alphanumeric Systems
Contact Detail:
Alphanumeric Systems Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Senior Specialist (SME) - 100% Remote (based in the UK)
✨Tip Number 1
Familiarize yourself with the latest pharmacovigilance regulations and guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals in the pharmacovigilance community, especially those who have experience with ICSR Management. Engaging in discussions on platforms like LinkedIn can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to process development and maintenance of written standards in your previous roles. Highlighting your practical experience will set you apart from other candidates.
✨Tip Number 4
Since this role is remote, emphasize your ability to work independently and manage your time effectively. Share any relevant experiences that showcase your self-motivation and organizational skills.
We think you need these skills to ace Pharmacovigilance Senior Specialist (SME) - 100% Remote (based in the UK)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in pharmacovigilance and process development. Emphasize your ability to create and maintain written standards, as well as any experience with ICSR management.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific examples of how your skills align with the responsibilities listed in the job description, particularly your experience with SOPs and regulatory compliance.
Showcase Your Expertise: As this role requires you to act as a subject matter expert, be sure to include any relevant certifications or training in pharmacovigilance. Highlight your problem-solving skills and ability to work in a complex matrix environment.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no grammatical errors or typos, as attention to detail is crucial in pharmacovigilance roles.
How to prepare for a job interview at Alphanumeric Systems
✨Show Your Expertise in Pharmacovigilance
Be prepared to discuss your experience with pharmacovigilance systems and ICSR management. Highlight specific projects where you contributed to process development or maintained written standards, as this will demonstrate your capability as a subject matter expert.
✨Demonstrate Problem-Solving Skills
Since the role involves identifying and addressing issues within PV Operations, come equipped with examples of how you've successfully navigated challenges in previous roles. Discuss any corrective/preventative actions (CAPAs) you've implemented and their outcomes.
✨Emphasize Your Communication Skills
In a remote setting, clear communication is key. Be ready to explain how you effectively collaborate with teams across different locations. Share experiences where you facilitated discussions or provided training to enhance team knowledge in ICSR management.
✨Prepare for Questions on Time Management
Given the need to prioritize work according to business needs, think of instances where you successfully managed multiple tasks or projects. Be ready to discuss your strategies for staying organized and meeting deadlines in a fast-paced environment.
