Manager, Drug Safety at Amneal Pharmaceuticals LLC (J0P) in Brookhaven, New York

Job Description:

Description:

• This position is responsible for the oversight of drug safety specialist functions and daily activities of the vendor managed call center ensuring compliance with all applicable SOPs. Daily activities of the manager include managing of product-related complaints and inquiries, coordination with third parties and other departments, maintenance of documentation, training of staff, and maintenance of audit-ready status.

Essential Functions:

• Oversee, support and perform vendor management for Amneal Call Center, Patient Support Programs. Metrics overview, trending reports, gap analysis, staffing resources, database configuration and management, corrective & preventative action execution and will oversee the vendor managed call center activities, processes and practices according to applicable company policy, utilizing approved call center tool. • Actively lead the call center representatives in all market actions (Recalls, Patient safety advisory) involving Amneal's product and proactively review call center responses to ensure accuracy, compliance and ensure that medical inquiries are addressed and closed within appropriate time lines. . Manage the process of conducting effective case follow-up with patients and customers, and collaboration with interdepartmental teams for investigation activities and FDA reporting obligations. .Vendor Auditing: Provides leadership in the area of call center performance including vendor and internal staff mentoring, auditing, productivity monitoring and coaching for success. .Oversees the Business Partner Reconciliation for adverse drug events related to case exchange activities to eliminate the potential for compliance exposure by ensuring SDEAs commitments are adhere to. Plan and track all aspects of the call center budget, including invoicing

• Supervision of Drug Safety Specialist and their functions and processes with compliance with cGMP, FDA regulations and guidance, company’s Standard Operating Procedures (SOPs) and Industry Best Practices. . Serve as a point of escalation for issues requiring a higher degree of expertise or discretion to resolve prior to forwarding to appropriate departments (Legal Escalation). . Performance of preliminary evaluation/assessment to assign for a potential escalation

• Collaboration: . Collaborate with Customer Service, Pharmacovigilance, Quality groups and other internal stakeholders in processing customer inquiries, adverse events, and product complaints per Company policies/ SOP. . Actively participate as the call center representative in assigned REMS programs . Liaise with Product Launch Team for awareness and preparedness of New Product Launch initiatives.

• Document Management: Responsible for creating and maintaining documents (FAQ, SOP, Work Instructions) and processes related to call center database (IRMS, QUMAS, Calibre. Initiates/authors Planned Deviations and Notice of Investigations (NOIs).

• Data Analysis: Monitor call center volume, metrics and performance, prepare weekly reports, analyze and disseminate the data to assist management in goal setting/prioritize. Analyze reporting data trends and signals within call center activities to ensure efficiency and productivity is maximized. Provide feedback to team related to productivity and efficiency.

Additional Responsibilities:

• Collaborates and Manages Functions as follow:

• • Liaise with Legal, Regulatory Affairs, Labeling, Sales & Marketing, Amneal Institutional and Specialty Business Divisions and/or Quality Management Unit to generate responses to request for product information, detection of potential litigation matters and potential FDA Field Alert Cases.

• • Manages and supports call center training and resources allocation/new hiring.

• Support Business Integration Activities. Reviews SDEAs, Quality Agreements, Business Rules and SOWs (Statement of Work) on Ad-hoc basis.


• Collaborates with stakeholders to develop and manage telephone script recordings in key areas of 800#s within the organization and Amneal.com website.


• • Prepares weekly/monthly status reports for departmental updates/meetings.

Education:

• Bachelors Degree (BA/BS) Bachelors degree in Science or Art or related field - Required

Experience:

• 5 years or more in 5+ years experience in pharmaceuticals or medical related or Customer service experience with supervisory experience in pharmaceutical or patient engagement.

Skills:

• Good written and oral communication skills - Advanced

• Ability to work independently in a Matrix Organization - Advanced

• Ability to deal with angry customers and extract required information - Advanced

• Ability to make sound compliance judgments and medical evaluations. - Advanced

Specialized Knowledge:

• Familiarity with drug product, adverse event and medical terminology

• Knowledge of GMPs and FDA complaint handling guidance. knowledge of FDA regulations, GMP/GLP/GCP

• proficient with Microsoft Word, Excel, Power point

• Knowledge of United States federal regulations pertaining to the provision of medical information and fair and balanced promotion of medicines

• Knowledge of medical information processes and industry standards