Pharmacovigilance Account Manager

Regulartory Affairs Philadelphia, Pennsylvania


Description

Selected as Fortune’s #1 Fastest Growing Company, Lannett is the fast-forward leader in the manufacture of generic pharmaceuticals as well as being a one-stop, blend to bottle manufacturer.  We are seeking highly talented and self-motivated professionals to join our rapidly growing company. 

 

We are seeking a detail oriented person to join our Corporate Quality Assurance Department as a Pharmacovigilance Account Manager at our Philadelphia facility. This position is primarily responsible for the oversight of the pharmacovigilance service provider, Ashfield Pharmacovigilance (APV), for all development and marketed products for Lannett and its subsidiary companies, ensuring that Lannett is complaint with the necessary regulatory agencies. This also includes oversight of Ashfield’s Call-Center and Medical Information activities supporting Lannett and its subsidiary companies ensuring that adequate triaging of product complaints, pharmacovigilance, customer service requests, and medical information requests are properly being triaged and addressed.  

 

Job Summary:

 

This position is responsible for the oversight and initiation of drug safety and pharmacovigilance activities for marketed and development products.    The Pharmacovigilance Manager is responsible for receiving and processing Adverse Events (AEs) reported to the company from any internal or external source for products sold or distributed by the company. The incumbent is the primary contact and liaison for all contract Pharmacovigilance (PV) and Risk Evaluation and Mitigation Strategies (REMS) activities.  This position will be responsible for working with contract research organizations (CROs) and other vendors to adequately establish and maintain PV and REMS programs.

 

Essential Duties:

 

  • Interact with internal and external stakeholders to intake, triage, document, and follow-up on AEs according to company Standard Operating Procedures (SOPs). Forward product quality complaints to the Quality Assurance Department, as required.

  • Work with individuals in each division and across various departments (e.g., regulatory affairs, clinical R&D, and quality assurance) involved with the Pharmacovigilance process.

  • Coordinate investigations with the Quality Assurance department, as needed.

  • Author, review and revise SOPs governing the PV and REMS functions.

  • Coordinate all FDA adverse drug experience reporting activities with the Regulatory Affairs department and contract organizations.

  • Act as the primary contact and liaison between Lannett and its affiliates for contract pharmacovigilance oversight.

  • Facilitate any FDA pharmacovigilance audits to ensure that all questions and matters are adequately addressed.

  • Act as the company representative on REMS program committees to ensure company interests are properly considered and decisions made are in alignment with corporate requirements.

  • Manage, forecast and set budget requirements for the Pharmacovigilance and REMS systems.

  • Prepare quarterly updates for Senior Management highlighting any key or significant issues and resolutions.

  • Prepare, manage and track safety agreements with third parties, including ongoing reconciliation.

  • Assist in auditing CROs who manage and handle pharmacovigilance and REMS responsibilities on behalf of Lannett.

 

Supervisory Responsibilities

  • May supervise staff to help manage tracking of AEs and REMS programs for Lannett.

 

Training or Experience

  • Minimum of 5 years in Drug Safety/Pharmacovigilance management in the Pharmaceutical Industry

  • Strong knowledge of FDA requirements related to Pharmacovigilance and REMS programs

 

Education

  • RPh., RN, LPN, or other Licensed Healthcare Professional