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. 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.
The role
The Pharmacovigilance (PV) Specialist, Case Processing manages individual case safety reports, performs initial case-level 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.
Please note this is for a 12 month Fixed term position.
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.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
