Job Information
Cline Davis & Mann Global Adverse Event and Compliance Coordinator in Doylestown, Pennsylvania
Overview
The Adelphi Group is a pharmaceutical consultancy business working with the major global pharmaceutical companies. Adelphi Group has a global network of offices across the US, Europe and Asia with 1,000 staff worldwide. One of the core Adelphi businesses is market research consisting of several agencies in this space. As a global provider of market research, Adelphi operates in a demanding and ever-changing compliance environment.
Title :Global Adverse Event and Compliance Coordinator
Location : The Planning Shop
Background on Compliance -
In order to comply with global safety regulations, pharmaceutical companies are required by law to collect and evaluate all adverse events and product complaints associated with their products. Currently, The Planning Shop and Adelphi Research must identify and report all adverse events (AE) attributable to drugs manufactured by our pharmaceutical clients which are reported during market research. AE reports help our clients ensure drug quality and patient safety, and provide important safety information, which may not have been identified during clinical trials. As an “agent” of the pharmaceutical company, we are legally obligated to comply with these regulations. Non-compliance may result in substantial penalties for our clients and loss of business for us. Procedures for reporting AEs and for training our employees vary by client. Many clients require that a record of AEs be maintained for a minimum of two years, and require a reconciliation upon project completion, which is a list of all AEs reporting during the research.
Job purpose -
This global role will cover agencies in the UK and US. With the support and direction of the Director of Compliance, you will ensure that The Planning Shop and Adelphi Research’s internal and client-specific processes are followed in order to provide compliance with all relevant country specific legislation, all professional codes of conduct/practice, rules and regulations of regulatory agencies and client specific policies and procedures.
Responsibilities and Accountabilities:
Adverse Event (AE) Reporting
To assist in the responsibility for the coordination of AE reporting ensuring client specific processes are followed.
Help maintain our internal database for AE reporting.
Ensure that all Adelphi training records are filed and logged in the client folders and that all internal systems are updated with the relevant client specific information. Ensure that appropriate records are maintained to meet client specific and regulatory requirements.
Provide support in the AE review of data collection materials including review of the AE rule document.
Provide support with client-specific processes, including interaction dates, reconciliations, and source data verification.
Review data for potential AEs and complete Source Data Verifications.
Assist in organizing, liaising, and managing 3rd party coverage for AE reporting when required.
Alert staff to AE requirements when new projects are awarded, providing tools to ensure compliance (i.e., quick reference guides, forms, and where possible, client products lists)
Assist in ensuring tasks and activities are performed according to client specifications, procedures and policies.
Assist in ensuring that Adelphi’s Market Research agencies are in compliance with all specific client AE documentation and regulations.
Audits
Support necessary internal preparations for the external ISO annual audit, liaising with the Senior Mgt Team and Group Compliance.
Support in conducting internal audits and raise corrective actions as specified by the Compliance Director.
Assist in the preparation of documentation to meet regulatory and specific client requirements, such as SOPs.
Project Close-Out process
Support in the management all compliance aspects of the project close out process.
Data Privacy
Provide project teams basic knowledge of global data privacy requirements and specific client privacy requirements.
Requirements
Bachelor’s Degree or 2+ years of general office experience preferred.
Good analytical/judgment capabilities to understand/analyze/synthesize and communicate.
Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
Able to lead internal training and meetings.
Proficiency in Word, Excel and PowerPoint.
Ability to work in global environment and cross-functional team, with good interpersonal skills/assertiveness/team spirit.
Strong project management skills.
The range below represents the low and high end of the base salary someone in this role may earn as an employee of an Omnicom Health Group company in the United States. Salaries will vary based on various factors including but not limited to professional and academic experience, training, associated responsibilities, and other business and organizational needs. The range listed is just one component of our total compensation package for employees. Salary decisions are dependent on the circumstances of each hire.
- $45,000 - $50,000
Omnicom Health Group is committed to hiring and developing exceptional talent. We agree that talent is equally distributed, and we’re focused on developing diverse teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join us—we look forward to getting to know you.
Company THE PLANNING SHOP Category Operations Location US-PA-Doylestown Job ID 2024-44670 LI #LI-CP1