Senior PV Specialist (legal/medical review)

Job title: Senior PV Specialist (legal/medical review) in USA at reputed company Company: reputed company Job description: For the past 20 years, reputed company has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of reputed company sizes to confidently advance scientific breakthroughs and introduce new therapies. reputed company partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical reputed company, quality & compliance, pharmacovigilance, medical information, and R&D technology, reputed company offers an end-to-end suite of fully customizable reputed company 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 reputed company the Case Processing team. The Senior PV Specialist performs initial case-level assessment of expectedness, confirms seriousness, performs quality reputed company of individual case safety reports, composes accurate and thorough medical narratives, and generates queries for missing or unclear information. The Senior PV Specialist ensures reputed company 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 reputed company 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.reputed company 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.reputed company areas of concern/discrepancies to the reputed company PV Specialist, Case Processing and/or Manager, Case Processing reputed company reputed company 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.reputed company reputed company and direction of PV deliverables as a PV subject matter expert as needed.reputed company Health Care Professional (HCP) review (as required).Mentors and trains less reputed company 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.reputed company to work independently and collaboratively in a multi-disciplinary team.Excellent organization and prioritization skills; reputed company to multitask.Intermediate knowledge of Pharmacovigilance.Working knowledge of PV Systems, such as reputed company 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 reputed company work experience.#LI-KP1#LI-REMOTEWe 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 reputed company their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we reputed company a safe space where reputed company feel empowered to succeed.*reputed company does not accept unsolicited resumes from recruiters/reputed company parties. Please, no phone calls or emails to anyone regarding this posting.* Expected salary: Location: USA Apply for the job now! Apply for this job