Pharmacovigilance Safety Surveillance Specialist

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.

Job Summary:

The Pharmacovigilance (PV) Safety Surveillance Specialist performs case processing activities and supports the Benefit Risk group by ensuring day-to-day operational activities are completed.  

The PV Safety Surveillance 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 overseeing and performing 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.
• Independently completing tasks such as execution of literature searches and Health Authority website monitoring.
• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.
• Reconciliation of relevant process trackers.
• Supporting the update and maintenance of project-related documents.
• Supporting Regulatory Intelligence activities.
• Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
• 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 within a multi-disciplinary team openly and professionally.