Sr. Specialist, Pharmacovigilance

Overview

Being on medication is tough enough. We want to make getting it the easy part. Getting prescriptions to patients has become increasingly complex. When things get messy along the prescription journey, pharmaceutical manufacturers rely on us to untangle the process and create a clear path - allowing patients to build trusting relationships with their medication brands.

We’re not only committed to taking the pain out of the prescription process, but we’re also devoted to bringing the brightest minds together under one roof. We bring together diverse voices - engineers, pharmacists, customer service veterans, developers, program strategists and more - all with one vision. Each perspective and experience makes ConnectiveRx better than the sum of its parts.

Under direct supervision of the department manager/supervisor, the Sr. Specialist, Pharmacovigilance is focused on meeting ConnectiveRx’s obligations for Drug Safety Monitoring and Reporting as required by the pharmaceutical programs and drug manufacturers we support. The Sr. Specialist, Pharmacovigilance works to ensure that ConnectiveRx is operating in a constant state of control and audit-readiness with regard to our contractual obligations and applicable laws and regulations related to Pharmacovigilance activities.

Responsibilities

• Handling escalated concerns from clients, junior level Pharmacovigilance (PV) staff and/or Contact Center employees related to Pharmacovigilance, providing advice and recommendations on best practices, coaching leaders and contact center staff on PV matters, troubleshooting problems, documenting and performing Corrective and Preventive Actions (CAPA) when major or minor non-conformances are identified.
• Reviewing Pharmacovigilance reports created by ConnectiveRx associates to ensure that the report contains an accurate and complete description of the information as relayed to the ConnectiveRx associate, that reporting form(s) and portal(s) are used appropriately, entering into ConnectiveRx’s Quality Management database and the manufacturer’s database (if required), submitting reports to drug manufacturer on time. Performing audits of calls, faxes, and other forms of communication from patients, healthcare providers to ensure all Pharmacovigilance data is captured and reported.
• Under the guidance/direction of the Manager of Pharmacovigilance perform periodic reconciliation activities, which involves extracting relevant data from the Quality Management System database and other systems (such as, but not limited to: phone systems, CRM systems, etc.), reporting the total number of Pharmacovigilance reports sent to manufacturers within a particular time period, providing any additional information requested by the manufacturer quickly and concisely, reconciling manufacturer records for the same time period with those of ConnectiveRx to highlight and resolve any discrepancies, and ensuring no reports were missed or provided late or incomplete to the manufacturer’s Drug Safety Department.
• Evaluating and updating ConnectiveRx Standard Operating Procedures (SOPs) and Work Instructions related to Pharmacovigilance processes as needed to ensure compliance with all relevant contract agreements, company and client policies and applicable regulations.
• Working to maintain a constant state of training compliance to meet manufacturer expectations, frequently creating pharmacovigilance educational content and either leading or assisting the Manager of Pharmacovigilance with pharmacovigilance training for new employees.
• Working with the legal and contract team to review content in new or revised draft client contract agreements to ensure that all content related to Pharmacovigilance are aligned with ConnectiveRx capabilities and service offerings.
• Monitoring compliance to the ConnectiveRx Pharmacovigilance program through various means such as (but not limited to) call monitoring, review of original source documents, direct observation, internal auditing, quality assurance/quality control activities, as directed by the Manager of Pharmacovigilance. Documenting the results of such compliance monitoring according to the ConnectiveRx Quality Management System.
• Other duties as assigned, including assisting Enterprise Quality leadership with RFP and audit support, and preparation for 3rd party audits. Performing audits of ConnectiveRx subcontractors and suppliers with respect to Pharmacovigilance activities.

Qualifications

Education/Degree Requirements/Certifications

• Bachelor’s or master’s degree in science or healthcare field, or 7 years equivalent experience.

Experience

• 3-5 years of experience in a medical, pharmacy or healthcare environment (preferably call center or claims processing), and/or HUB service operations center required.
• Quality control / Quality Assurance experience is a plus.

Knowledge

• Must have a very solid understanding of the principles of the FDA regulations related to Postmarketing Safety Reporting requirements under 21 CFR 314.80 and 21 CFR 822, as well as how these principles impact ConnectiveRx’s business and obligations to the drug manufacturers we support.
• Must be able to positively identify and classify various types of reportable drug safety events such as serious and non-serious adverse events, other safety information and product quality complaints.
• Basic understanding of medical and clinical terminology.

Skills

• High level of reading and verbal comprehension (English required, Spanish or other languages considered a plus) required to interpret audio and text source data.
• Competency in clearly and concisely articulating medical and clinical information to manufacturer representatives.
• Must utilize problem-solving skills to resolve concerns and escalated issues.
• Familiarity and high degree of proficiency with basic office tools such as the Microsoft Office suite (Outlook, Word, Excel, PowerPoint) and ability to learn and successfully utilize other Quality System tools such as (not limited to) Trackwise Digital/Sparta and Talent LMS.

Competencies

• Process Knowledge: Identifies, documents, and monitors key processes needed to achieve successful business results. Maps and documents processes. Develops framework for process improvement. Identifies and documents processes within area of responsibility. Seeks guidance on aspects of process that are out of immediate scope. Drafts procedures that comply with the process. Implement process improvement recommendations within the context of overall business processes.
• Decision Quality: Ability to make appropriate, informed and timely decisions while ensuring compliance with company policies, practices and core values. Uses a combination of analysis, knowledge, experience, and judgment to make decisions. Makes effective decisions, even in the absence of complete information. Evaluates and prioritizes factors, weighs decisions in order to reach a sound and effective solution to a problem.
• Service Orientation: Anticipate, identify, and address the needs of customers/clients, sometimes before those needs are voiced. Actively looks for ways to help people; ability to be thoughtful, empathetic to the needs of others. Is prompt and courteous in ensuring that the customer's immediate needs or complaints are satisfied. Focuses on improving the level of service provided to external and internal customers.
• Consultation Communication: The ability to provide guidance to organizational stakeholders. Offers solutions based upon best practices, generates specific organizational interventions (e.g., culture change, change management, restructuring, training, etc.) to support organizational objectives.

Travel or Physical Requirements

• Up to 15% travel may be required.
• While performing the duties of this job, the employee must be able to:
• Perform primarily sedentary work with occasional lifting up to 20 pounds, and exerting up to 10 pounds of force occasionally, and a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
• A majority of the work day is in an office environment. Must see, hear, talk and perform tasks requiring visual acuity, manual dexterity, grasping and other similar tasks requiring physical activity and repetitive motions.
• Operate standard office and computer equipment, and spend a majority of work day communicating with other employees and external contacts, both via telephone and in writing.

Compliance Requirements

• Adhere to all Company Policies, Procedures, and other training consistent with ConnectiveRx's Information Security and Compliance Programs, including but not limited to the following compliances and regulations: SOC1, SOC2, PCI, HIPAA.
• Maintain strict compliance with company and client policies regarding business rules and ethics, as well as applicable local, state and national federal laws.

Compensation & Benefits: Compensation for this role varies based on factors such as location, relevant skills, experience, and capabilities.

Employees at ConnectiveRx can enroll in comprehensive benefit plans, including medical, dental, vision, life, and disability insurance. The company retains the right to update or modify health, welfare, and other fringe benefit policies. Employees may also participate in the company's 401(k) plan.

Time-Off & Holidays: ConnectiveRx provides paid time off (PTO) to non-exempt employees for vacations and personal leave. For sick leave, eligible non-exempt employees receive Sick Time Off (STO) in accordance with company policy. PTO and STO are prorated during the first year of service. Employees also receive eight standard company holidays and three floating holidays annually, with floating holidays prorated in the first year.

The company is committed to maintaining competitive benefits and reserves the right to adjust employee offerings, including PTO, STO, and holiday policies, in compliance with applicable laws and regulations.

Posted Salary Range USD $61,000.00 - USD $92,100.00 /Yr.