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.
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
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.
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.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please no phone calls or emails to anyone regarding this posting.***
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.