Senior PV Specialist (legal/medical review)

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.

The Senior Pharmacovigilance (PV) Specialist, Case Processing is primarily responsible for peer review of cases within the Case Processing team. The Senior PV Specialist performs initial case-level assessment of expectedness, confirms seriousness, performs quality check of individual case safety reports, composes accurate and thorough medical narratives, and generates queries for missing or unclear information. The Senior 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 Senior 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 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.

• 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.

• Provide oversight and direction of PV deliverables as a PV subject matter expert as needed.

• Perform Health Care Professional (HCP) review (as required).

• Mentors and trains less experienced staff.

• Other duties as assigned.

Necessary Skills and Abilities:

• Strong verbal, written and interpersonal communication skills. 

• Intermediate project management 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. 

• Intermediate knowledge of Pharmacovigilance.

• Working knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases. 

• Legal/Medical case review experience preferred.

Educational Requirements:

• Required: a Bachelor's degree in life sciences.

• Preferred: an advanced degree, RN, RPh, PharmD or equivalent. 

Experience Requirements:

Three years of related work experience.

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