Pharmacovigilance Specialist Clinical Case Processing

1 week ago

London, Greater London, United Kingdom Lifelancer Full time

Job Title: Pharmacovigilance Specialist Clinical Case Processing 12 Month FTC

Job Location: London UK

Job Location Type: Remote

Job Contract Type: Fulltime

Job Seniority Level: Entry level

For the past 20 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. As the world's largest RCO (Research Consulting Organization) ProPharma partners with its clients through an advisebuilrate 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 endtoend suite of fully customizable consulting solutions that derisk and accelerate our partners' most highprofile drug and device programs.

The Role

The Pharmacovigilance (PV) Specialist Clinical Case Processing manages individual case safety reports performs initial caselevel assessment of expectedness confirms seriousness composes accurate and thorough medical narratives and generates queries for missing or unclear information. The PV Specialist ensures all cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines Working Practices SOPs and applicable safety regulations. The PV Specialist maintains distinctive quality and commitment as the operating philosophy in carrying out all processes and continually seeks out ways to enhance customer service experience both internally and externally.

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 followup.
  • 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 uptodate 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
  • Fluency in English is a must both verbally and written
  • 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 multidisciplinary team.
  • Excellent organization and prioritization skills; able to multitask

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

Experience Requirements
  • One to two years experience working in Pharmacovigilance within a case processing environment ideally using the Argus is critical for success

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.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please no phone calls or emails to anyone regarding this posting.***

Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.

For more details and to find similar roles please check out the below Lifelancer link.

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Key Skills
Project Portfolio Management,Motivational Interviewing,HIPAA,Computer Skills,Intake Experience,Lean Six Sigma,Conflict Management,Case Management,Team Management,Program Development,Social Work,Addiction Counseling
Employment Type : Full Time
Experience: years
Vacancy: 1

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