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- Tasks: Lead and manage pharmacovigilance services while ensuring compliance and quality.
- Company: Join a dynamic team focused on global safety regulations in the pharmaceutical industry.
- Benefits: Enjoy opportunities for mentorship, professional growth, and collaboration with experts.
- Why this job: Make a real impact in patient safety while developing your skills in a supportive environment.
- Qualifications: Bachelor's in life sciences required; advanced degrees preferred with four years of experience.
- Other info: Ideal for self-motivated individuals who thrive in a fast-paced, multidisciplinary team.
The predicted salary is between 48000 - 72000 £ per year.
Principal Pharmacovigilance Specialist, Case Processing
The Principal Pharmacovigilance (PV) Specialist, Case Processing is primarily responsible for directional leadership of PV clients that are contracted for an extensive suite of PV services while collaborating with Client Services on standard service offerings. The Principal PV Specialist serves as a subject matter expert of PV to assist in creating related project documents and guidance as needed. The Principal PV Specialist, Case Processing acts with limited oversight and ability to research, implement and manage PV services as contracted or requested; is responsible for maintaining a working knowledge of Global PV requirements for marketed products; and ensures compliance with all applicable regulations and internal SOPs. The Principal PV Specialist also assists the team with peer review and data entry as needed.
Essential Functions:
- Provide oversight and direction as a PV subject matter expert, enhancing client service internally and externally.
- Oversee the development of detailed project/program specific, Working Practices, Work Instructions, and other documents as applicable (e.g., Safety Data Exchange or PV Agreements).
- Serve as a resource for Case Processing team for complex cases and escalated inquiries.
- Perform case follow up activities such as identification of information to be collected during follow-up.
- Creating and reviewing case narratives.
- Providing client notifications as required for case management.
- Supporting and contributing to the development of training materials and training delivery.
- Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs.
- Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
- Peer reviews of cases for quality, consistency, and accuracy as needed.
- Perform Health Care Professional (HCP) review (as required).
- Mentors and trains less experienced staff.
- Other duties as assigned.
Necessary Skills and Abilities:
- Strong verbal, written and interpersonal communication skills with clients, external and internal staff.
- Excellent project management skills.
- High level of accuracy and attention to detail.
- Advanced problem-solving skills and ability to resolve problems in a timely manner.
- Able to work independently and collaboratively in a multidisciplinary team.
- Excellent organization and prioritization skills with attention to detail.
- Advanced Knowledge of Pharmacovigilance.
- Advanced knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases.
- Self-motivated to maintain high efficiency and productivity levels and manage multiple projects and clients.
Educational Requirements:
- Required: a Bachelor's degree in life sciences.
- Preferred: an advanced degree, RN, RPh, PharmD or equivalent.
Experience Requirements:
Four years of related work experience.
Principal Pharmacovigilance Specialist employer: ProPharma
Contact Detail:
ProPharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Pharmacovigilance Specialist
✨Tip Number 1
Make sure to highlight your experience in pharmacovigilance and case processing during networking opportunities. Attend industry conferences or webinars where you can connect with professionals in the field and discuss your expertise.
✨Tip Number 2
Familiarize yourself with the latest global safety regulations and PV systems like Oracle Argus Safety or ARISg. This knowledge will not only boost your confidence but also demonstrate your commitment to staying updated in the field.
✨Tip Number 3
Consider reaching out to current or former employees of StudySmarter on LinkedIn. They can provide valuable insights into the company culture and expectations for the Principal Pharmacovigilance Specialist role.
✨Tip Number 4
Prepare to discuss specific examples of how you've managed complex cases and mentored less experienced staff. This will showcase your leadership skills and ability to enhance client service, which are crucial for this position.
We think you need these skills to ace Principal Pharmacovigilance Specialist
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Principal Pharmacovigilance Specialist position. Understand the key responsibilities and necessary skills, as this will help you tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in pharmacovigilance, particularly any leadership roles or project management experience. Mention specific systems you have worked with, such as Oracle Argus Safety or ARISg, to demonstrate your technical expertise.
Showcase Communication Skills: Since strong verbal and written communication skills are essential for this role, provide examples in your application that showcase your ability to communicate effectively with clients and team members. Consider including instances where you successfully managed complex inquiries or mentored less experienced staff.
Tailor Your Documents: Customize your CV and cover letter to reflect the language and requirements mentioned in the job description. Use keywords from the listing, such as 'project management', 'attention to detail', and 'advanced problem-solving skills' to ensure your application stands out.
How to prepare for a job interview at ProPharma
✨Showcase Your Expertise
As a Principal Pharmacovigilance Specialist, it's crucial to demonstrate your deep understanding of pharmacovigilance. Be prepared to discuss specific regulations and guidelines you've worked with, and how you've applied them in past roles.
✨Highlight Project Management Skills
Since the role requires excellent project management skills, come ready to share examples of projects you've managed. Discuss how you organized tasks, prioritized responsibilities, and ensured compliance with internal SOPs.
✨Demonstrate Communication Abilities
Strong verbal and written communication skills are essential. Prepare to discuss how you've effectively communicated with clients and team members, especially in complex case scenarios or when providing training.
✨Prepare for Case Processing Scenarios
Expect questions related to case processing and follow-up activities. Be ready to explain your approach to identifying information needed during follow-ups and how you ensure accuracy in case narratives.
