Senior PV Specialist (legal/medical review)

ProPharma Group; London; On-site; GBP 40,000 - 70,000; Full time

Job summary

Join a forward-thinking organization as a Senior PV Specialist, where your expertise in pharmacovigilance will play a crucial role in ensuring patient safety. This position involves overseeing case processing, conducting quality reviews, and mentoring team members. You'll be part of a dynamic environment that values collaboration and innovation, working alongside a passionate team dedicated to advancing healthcare solutions. If you're ready to make a meaningful impact in the pharmaceutical industry, this opportunity is perfect for you.

Qualifications

• 3+ years of experience in pharmacovigilance or related fields.
• Strong communication and project management skills essential.

Responsibilities

• Oversee daily case processing of adverse event cases.
• Perform quality checks and peer reviews of case safety reports.
• Develop training materials and mentor junior staff.

Skills

Verbal communication

Written communication

Interpersonal communication

Project management

Attention to detail

Problem-solving

Team collaboration

Organization skills

Pharmacovigilance knowledge

Education

Bachelor's degree in life sciences

Advanced degree (RN, RPh, PharmD)

Tools

Oracle Argus Safety

ARISg

Job description

Senior PV Specialist (legal/medical review)

Senior PV Specialist (legal/medical review)

Apply locations: United Kingdom, Belgrade, Zagreb, London, Sarajevo

Time type: Full time

Posted on: Posted 3 Days Ago

Job requisition id: JR 6855

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

The Senior PV Specialist 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 checks 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.

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.