Pharmaceutical Compliance Specialist

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

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⏰ Full Time

🟢 Junior

🚔 Compliance

👻 Ghost score 25%

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Lifelancer

51 - 200 employees

Founded 2020

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• Support the REMS Call Center program to help ensure FDA-mandated requirements and goals are met • Conduct investigations of potential non-compliance within REMS programs • Manage prompt, thorough, confidential, and objective investigations in accordance with Syneos Health and REMS Program requirements • Complete program compliance duties, including stakeholder re-education, documentation of non-compliant events, review of alerts/reminders, and healthcare provider/pharmacy follow-up • Coordinate corrective actions with stakeholders and ensure timely implementation • Provide training and education to contracted SPs and/or SDs about the program, processes, and data requirements • Engage in REMS program auditing and/or monitoring activities

🎯 Requirements

• Bachelor’s Degree required • Experience with Risk Evaluation and Mitigation Strategy (REMS) • Knowledge of call center operations and processes • One or more years of experience in the pharmaceutical or healthcare industry, with emphasis on compliance • Telephone and/or customer service experience and etiquette • Efficient computer and data entry skills; ability to learn new systems and programs quickly • Ability to work with a team and maintain a positive attitude • Clear and effective written and verbal communication skills • Ability to multitask, prioritize day-to-day responsibilities, and meet deadlines • Excellent analytical, problem-solving, and organizational skills • Experience in a high-pressure and fast-paced environment • Ability to maintain confidentiality involving compliance and company information and activities • Current working knowledge of rules, regulations, and industry guidance relevant to healthcare compliance • Ability to communicate effectively with Engagement Center representatives, internal departments, clients, and management • Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, or similar electronic mail program • Proficiency with investigation databases and case management systems and tools

🏖️ Benefits

• Competitive compensation package • Medical, dental, and vision health benefits • Company match 401(k) • Flexible paid time off (PTO) • Sick time • Diverse, inclusive, and authentic workplace • Support, resources, and autonomy • Opportunities to develop and advance • Voluntary COVID-19 vaccination policy; vaccination may be required by certain local governments or customers

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