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Principal Pharmacovigilance Specialist, Case Processing - Fixed Term Contract - Remote based

ProPharma
Full-time
On-site
Unknown

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. Please note, this is a fixed term contract which will run initially until the end of September 2026. 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. 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. 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. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Don’t see an open opportunity that matches your qualifications? Join our talent community to stay connected for potential future opportunities. Upload your resume/CV and contact details for our Talent Acquisition team to review and match for potential future opportunities. While you are here, sign up for Job Alerts to receive alerts of future opportunities that match your selected interests. To change the language, click on "English" at the top right corner of the screen and select your preferred language. If you are already signed in, click the cloud icon and go to Change Language. ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses (domain@propharmagroup.com). If you receive recruiting communications from anyone with a yahoo.com, gmail.com, live.com, propharmagroupjobs.com, or any other email account, it’s likely a fraud. Are you currently a ProPharma colleague? To be considered for an opportunity, please apply through the Jobs Hub in Workday.

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