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For Companies At a Glance
- Tasks: Lead pharmacovigilance compliance and oversee safety management for clinical trials.
- Company: Join a dynamic biotech firm focused on patient safety and drug development.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth.
- Why this job: Make a real impact in patient safety while working with cutting-edge technology.
- Qualifications: Bachelor’s in Science required; advanced degree preferred, with experience in drug safety.
- Other info: Ideal for those who thrive in fast-paced settings and love mentoring others.
The predicted salary is between 43200 - 72000 £ per year.
What You'll Do:
- Monitor CROs and business partners for compliance with Safety Monitoring Plans, study plans, metrics, KPIs, and contractual agreements
- Lead pharmacovigilance (PV) compliance, inspection, and audit readiness for Argus, KPIs, and safety management topics.
- Oversee ICSR workflow, case management activities in Argus (or other safety databases), ensuring critical timelines and compliance
- Provide pharmacovigilance oversight for clinical trials, post-market surveillance, and expanded access programs, ensuring integration of safety data
- Perform peer review of cases in safety databases, including adverse event coding, report tracking, and regulatory reporting as needed
- Triage incoming cases, assess seriousness, expectedness, and causality, and write high-quality case narratives for medical review
- Stay updated on regulatory requirements for safety management in Expanded Access and Compassionate Use Programs (EAPs/CUPs)
- Produce and submit safety reports (e.g., CIOMS/MedWatch Forms) to regulatory authorities, ensuring compliance with timelines
- Support the commercial team by participating in client calls, reviewing proposals, budgets, and presenting at bid defense meetings
- Act as system administrator for the company's global safety database (Argus), overseeing vendor relationships, system maintenance, and training
What You'll Need:
- Bachelor’s Degree in a Science or related field required; advanced degree (PharmD, MD, etc.) strongly preferred
- Experienced in drug safety/pharmacovigilance role in the biotech/pharmaceutical industry and/or in a CRO or clinical trial setting
- Proficient with International Council for Harmonization (ICH) Good Clinical Practices (GCP) guidelines and other applicable regulatory rules and guidelines, as well with medical terminology, clinical trials and clinical research
- Familiarity with and ability to effectively utilize safety databases needed. Knowledge of Argus Safety Database in an administration capacity is preferred
- Action-oriented and resilient in a fast-paced environment with strong project team skills and ability to mentor, delegate and motivate others
- Ability to communicate effectively with clients, internal teams and vendors and soft skills to build and maintain trust and confidence
- Strong understanding of global safety regulations, medical terminology, and drug development process
- Strong clinical background, with ability to interpret medical records (e.g., laboratory results, medical records) is a plus
Pharmacovigilance and Patient Safety Manager employer: Planet Pharma
Contact Detail:
Planet Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance and Patient Safety Manager
✨Tip Number 1
Familiarize yourself with the latest regulations and guidelines related to pharmacovigilance and safety management. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this fast-paced field.
✨Tip Number 2
Network with professionals in the biotech and pharmaceutical industries, especially those who work in pharmacovigilance. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends and challenges.
✨Tip Number 3
Gain hands-on experience with safety databases, particularly Argus. If you haven't worked with it before, consider online courses or tutorials to boost your proficiency, as this is a key requirement for the role.
✨Tip Number 4
Prepare to discuss specific examples from your past experiences where you successfully managed compliance and safety monitoring. Highlight your ability to lead teams and mentor others, as these soft skills are crucial for the position.
We think you need these skills to ace Pharmacovigilance and Patient Safety Manager
Some tips for your application 🫡
Tailor Your CV: Make sure to customize your CV to highlight your experience in pharmacovigilance and drug safety. Emphasize your familiarity with ICH guidelines, GCP, and any relevant safety databases like Argus.
Craft a Strong Cover Letter: In your cover letter, clearly articulate your passion for patient safety and your experience in managing compliance and oversight in clinical trials. Mention specific examples of how you've contributed to safety monitoring and regulatory reporting.
Highlight Relevant Experience: When detailing your work history, focus on roles that involved pharmacovigilance, case management, and regulatory compliance. Use metrics and KPIs to demonstrate your impact in previous positions.
Showcase Communication Skills: Since the role requires effective communication with clients and internal teams, provide examples in your application that showcase your ability to build relationships and convey complex information clearly.
How to prepare for a job interview at Planet Pharma
✨Show Your Expertise in Pharmacovigilance
Be prepared to discuss your previous experience in drug safety and pharmacovigilance. Highlight specific projects where you ensured compliance with safety monitoring plans and how you managed case narratives.
✨Demonstrate Knowledge of Regulatory Requirements
Familiarize yourself with the latest regulatory requirements for safety management, especially in Expanded Access and Compassionate Use Programs. Be ready to explain how you stay updated on these regulations.
✨Highlight Your Technical Skills
Discuss your proficiency with safety databases, particularly Argus. If you have experience as a system administrator, share examples of how you maintained the system and trained others.
✨Emphasize Communication and Teamwork
Prepare to showcase your ability to communicate effectively with clients and internal teams. Share examples of how you've built trust and confidence in past roles, especially in fast-paced environments.
