Head of Compliance

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Overview

Head of Compliance

Background
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.

The role
This global role will cover agencies in the UK and US. The individual is a compliance expert who ensures that the Adelphi Research Franchise complies with relevant legislation, regulatory requirements and internal policies. This position is responsible for maintaining a positive image of Adelphi in compliance externally with clients and professional bodies and internally with The Planning Shop (TPS), Adelphi Research (AR) and Adelphi Group.

Responsibilities

• Keep up to date with, and understand, relevant laws and regulations and client requirements in compliance. Assess the impact on Adelphi's systems and processes and disseminate information to AR and TPS.
• Monitor compliance with laws, regulations and internal policies throughout TPS and AR and develop robust and effective compliance controls. This will typically be done by conducting data protection audits throughout the business (required to comply with accountability under GDPR). Investigate irregularities and non-compliance issues and report back to business functions on current risk and compliance performance.
• Interact with operational leads in each research business and Adelphi Group to ensure all aspects of compliance are upheld in delivery of research projects. Work with Operations to ensure that supplier assessments, DPAs and MSAs are in place.
• Provide support and help with external audits (client, ISO etc.), including preparation for the audit, ensuring all information and project files are audit ready as well as the project and operations teams. Post audit, create corrective actions.
• Assist in the gathering of internal information in response to client requests, RFIs or audits and ensure that there is a consistent response to such requests. Ensure that knowledge from such requests/audits is disseminated to the AR and TPS compliance and operations teams.
• Build high level relationships with relevant Compliance client teams (Adverse Events; data protection etc.) and professional bodies. Seek opportunities to network with other market research industry organizations on compliance.
• Collaborate and liaise with the compliance leads in the other Adelphi Franchises to share best practices and learn from each other.
• Educate employees on the legislation/regulations and the impact to the organization of non-compliance.
• Manage compliance team across Research Franchise (TPS, ARUS and ARUK) and ensure consistency across the teams. Ensure capacity is managed across the Franchise, rather than at the agency level to maximize resources.

Specific Accountabilities
Quality Management

• Responsible for ensuring TPS and AR are following quality standards and operating procedures required for ISO 20252 certification. Prepare TPS for ISO certification.

SOPs/Audits

• Develop and implement Research Franchise standard operating procedures (SOPs).
• Work with Adelphi Group Compliance to ensure Group SOPs are adhered to within the Research Franchise.
• Ensure regular audits are conducted to verify adherence with internal SOPs and industry standards to meet regulatory and client-specific requirements.
• Internal Audits: Ensure internal audits specified in our SOPs are conducted during the required timeframes to assess compliance specified in the Adelphi Quality manual.
• Client audits: Responsible for preparation and participation in all client requested audits (general and pharmacovigilance).
• Certification Audits: Responsible for preparation and participation in Certification, recertification and surveillance audits for ISO.
• Review Operations processes once a year in each unit to ensure they are compliance sound. Provide feedback and corrective actions.

Client Risk Assessments

• Work with IT to ensure efficient completion of Client Risk Assessments, including completing any company-specific information associated with day-to-day practice in market research.

Security Evaluation Coordination

• Ensure third party security evaluations are completed for all external partners and tools used to support the market research process, by coordinating with the relevant parties within Adelphi Group and at Omnicom.

Ethical and Legal

• Provide support on ethical and legal responsibilities when conducting market research.
• Ensure processes and procedures to meet legal, regulatory and client-specific requirements are implemented.
• Review compliance-related aspects of agreements with clients, regulatory guidelines and updates and interpret and communicate information.

Data Privacy

• Expertise in global data privacy requirements (GDPR specifically) and specific client privacy requirements, ensuring all client requirements are adhered to and communicated throughout the company.

Project Compliance

• Conduct training, prepare and submit Adverse Event reports in compliance with market research standards and individual client requirements.
• Ensure the compliance teams provide high quality, consistent Adverse Event Reporting project and client-level support.

Skills and Competencies

• 5 years relevant experience in market research compliance desired but not essential
• Degree level qualified (2:1 as a minimum in a relevant area), ideally with a relevant advanced qualification.
• A Practitioners Certificate in Data Protection, or a minimum of Level 3 Data Protection training, CIPP/E or CIPM or equivalent training for GDPR compliance.
• Proficiency in Word, Excel and PowerPoint.
• A thorough, methodical approach with strong attention to detail.
• Strong project management skills.
• Strong communication skills.

Our commitment:

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.