Pharmacovigilance Specialist, Case Processing

ProPharma; Greater London; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

ProPharma is seeking a PV Case Processor to manage daily adverse event cases, including MedDRA coding and assessment of seriousness. You will follow up to gather required information and create narratives, while communicating with clients as needed.

The role supports training development and requires maintaining current knowledge of global safety regulations. The position offers hybrid work options and collaboration across a multi-disciplinary team.

Qualifications

• Bachelor's degree in life sciences required.
• Two years of related adverse event processing experience.
• Knowledge of MedDRA coding and PV case processing.
• Ability to work independently and within a multi-disciplinary team.
• Strong communication and attention to detail.
• Basic knowledge of Pharmacovigilance.

Responsibilities

• Daily case processing of adverse event cases, including MedDRA coding and assessing seriousness and expectedness.
• Follow-up activities to identify information needed for case management.
• Create and review case narratives.
• Provide client notifications as required for case management.
• Support development of training materials and delivery.
• Flag areas of concern to the PV Specialist/Case Processing Manager.
• Maintain up-to-date knowledge of global safety regulations for medicines.
• Peer reviews of cases for quality and accuracy.
• Other duties as assigned.

Skills

Communication skills

Attention to detail

Problem solving

Teamwork

Organization

Pharmacovigilance basics

Education

Bachelor's degree in life sciences

Advanced degree or equivalent (RN/RPh/PharmD)

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Essential Functions

• Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.
• 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.
• Other duties as assigned

Necessary Skills And Abilities

• Strong verbal, written and interpersonal communication skills.
• High level of accuracy and attention to detail.
• Ability to identify and resolve problems in a timely manner.
• Able to work independently and collaboratively in a multi-disciplinary team.
• Excellent organization and prioritization skills; able to multitask.
• Basic knowledge of Pharmacovigilance.

Educational Requirements

• Required: a Bachelor's degree in life sciences.
• Preferred: advanced degree, RN, RPh, PharmD or equivalent.

Experience Requirements

Two years of related work experience.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.