Principal Pharmacovigilance 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.

The Principal Pharmacovigilance (PV) Specialist, Case Processing is primarily responsible for directional leadership of PV clients that are contracted for an extensive suite of PV services while collaborating with Client Services on standard service offerings. The Principal PV Specialist serves as a subject matter expert of PV to assist in creating related project documents and guidance as needed. The Principal PV Specialist, Case Processing acts with limited oversight and ability to research, implement and manage PV services as contracted or requested; is responsible for maintaining a working knowledge of Global PV requirements for marketed products; and ensures compliance with all applicable regulations and internal SOPs. The Principal PV Specialist also assists the team with peer review and data entry as needed.

Essential Functions:

• Provide oversight and direction as a PV subject matter expert, enhancing client service internally and externally.

• Oversee the development of detailed project/program specific, Working Practices, Work Instructions, and other documents as applicable (e.g., Safety Data Exchange or PV Agreements).

• Serve as a resource for Case Processing team for complex cases and escalated inquiries.

• Manages the case processing workflow adhering to contractual and regulatory timelines in getting cases from intake to submissions.

• Ensures the timely assignment of JIRA tasks are implemented, assigned to the case processing team, and closed.

• 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.

• 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 with clients, external and internal staff.

• Excellent project management skills.

• High level of accuracy and attention to detail.

• Advanced problem-solving skills and ability to resolve problems in a timely manner.

• Able to work independently and collaboratively in a multidisciplinary team.

• Excellent organization and prioritization skills with attention to detail.

• Advanced Knowledge of Pharmacovigilance.

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

• Self-motivated to maintain high efficiency and productivity levels and manage multiple projects and clients.

Educational Requirements:

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

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

Experience Requirements:

• Four years of related work experience.

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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.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***