Principal Pharmacovigilance Specialist, Case Processing - 12 Month FTC

ProPharma
Sheffield
2 months ago
Applications closed

Related Jobs

View all jobs

Clinical Trial Assistant (Undergraduate Placement Year)

Principal Mechanical Design Engineer

Principal Biostatistician

Principal Building Services Engineer

Principal Scientist

Principal Bioinformatician

Principal Pharmacovigilance Specialist, Case Processing - 12 Month FTC


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.

Get the latest insights and jobs direct. Sign up for our newsletter.

By subscribing you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Tips for Staying Inspired: How Biotech Pros Fuel Creativity and Innovation

Biotechnology stands at the dynamic intersection of biology, technology, and engineering, shaping discoveries that redefine healthcare, agriculture, environmental protection, and more. Yet, long research timelines, strict regulatory frameworks, and constantly evolving knowledge can make it difficult to stay inspired. How do biotechnology professionals keep their creative drive alive in a field where each discovery could change the world—but also involves rigorous protocols and meticulous validation? Below, you’ll find ten practical tips for maintaining creativity and innovation in biotech. From launching side projects that test emerging methods to tapping into hackathons and reading the latest research, these strategies will help you cultivate fresh perspectives and invigorate your day-to-day work. Whether you’re a seasoned researcher, a newcomer to the lab bench, or someone navigating the business side of biotech, these insights can help sustain the passion you need to make a genuine impact.

Top 10 Biotech Career Myths Debunked: Key Facts for Aspiring Professionals

Biotechnology is an ever-evolving field at the crossroads of biology, chemistry, engineering, and data science. From developing life-saving therapies and vaccines to pioneering sustainable agricultural solutions, biotech careers encompass a breadth of opportunities that extend far beyond the confines of a research lab. Yet, despite its rapid growth and immense potential, myths and misconceptions continue to swirl around careers in biotechnology. At BiotechnologyJobs.co.uk, we see firsthand how inaccurate beliefs about entry requirements, salary expectations, or job security can discourage promising talent. It’s time to set the record straight. Whether you’re a biology undergraduate envisioning a future in research or a seasoned professional in another domain who’s curious about making the switch, this article will debunk the top myths surrounding biotech careers. We’ll examine why these misconceptions persist, and more importantly, reveal the dynamic and inclusive reality behind the industry’s cutting-edge work. So let’s separate fact from fiction. Read on to discover the genuine opportunities, roles, and progression pathways that await you in biotech.

Global vs. Local: Comparing the UK Biotech Job Market to International Landscapes

How to navigate opportunities, salaries, and work culture in biotechnology across the UK, the US, Europe, and Asia Biotechnology has steadily evolved from a specialised branch of life sciences to an influential force shaping healthcare, agriculture, environmental sustainability, and even digital technology through bioinformatics. From the development of groundbreaking gene therapies and vaccines to the engineering of sustainable biofuels and lab-grown foods, biotech has become one of the most innovative and impactful sectors worldwide. As such, the demand for skilled professionals—from research scientists to regulatory affairs experts—is on a steep upward trajectory. For job seekers looking to build or enhance their careers in biotechnology, understanding how different regional markets compare can be a game-changer. In this blog post, we examine how the UK biotech job market stacks up against that of the United States, Europe, and Asia. We’ll explore not only the scale of job demand and differences in salaries, but also important nuances around work culture and professional growth. For those considering remote or international positions, we’ll offer valuable insights to help you make informed decisions. Whether you’re a recent graduate from a life sciences programme, a seasoned researcher branching into industry, or a professional pivoting from a related discipline such as pharma or chemical engineering, the global biotech landscape is replete with opportunities. By assessing factors like salary expectations, cost of living, regulatory environments, and cultural norms, you’ll be better equipped to navigate the evolving biotech world—and thrive in a sector that’s reshaping our future.