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 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.
A Pharmacovigilance Specialist will manage pharmacovigilance cases through all process of case / ICSR / SAE handling. They will perform processing of adverse events, conduct follow up, write accurate and complete narratives in accordance with internal guidelines, SOP's. A Pharmacovigilance Specialist will maintain distinctive quality and commitment as the operating philosophy in carrying out all processes and continually seek out way to enhance the customer service experience both internally and externally.
Essential Duties and Responsibilities:
Follow up call intake for pharmaceutical, DS/OTC, medical food and medical device products
Conduct daily case processing of adverse event cases including: case follow up activities, identifying information to be collected during follow-up, conduct follow-up calls and prepare written communications to obtain follow-up information, MedWatch/CIOMS, E2B Preparation, and write case narratives
Completed client notifications as required for case management
Develop training materials
Conduct training presentations and on-the-job training for call center including the medical information and pharmacovigilance staff
Other duties as assigned
Qualifications
Education and Experience Requirements:
1+ years of experience in related field of expertise (Preferred)
Drug safety experience (Preferred)
Experience working with safety databases (Preferred)
Life Science degree
Necessary Skills and Abilities:
Proficient computer knowledge and computer keyboarding skills
Proficient with Microsoft Office Suite (Outlook, Word, Excel)
Excellent customer service skills
Strong verbal, written, and interpersonal communication skills
Strong writing skills
Excellent attention to detail
Strong organization and prioritization skills; ability to multitask
Strong decision making skills
Strong problem solving skills
Ability to work independently and collaboratively in a multidisciplinary team
Flexibility to adapt and meeting fluctuating business priorities
Ability to occasionally work extended and/or flexible schedule to meet client requirements.
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 is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
