About the company
My client was established in 1987, and has undergone several stage changes, which have resulted in it being one of the most recognized and respected global market research providers to the pharmaceutical and healthcare industries.
This company currently employs approx. 85 people who are mainly based in the office in West London and in the virtual office in North America. The organization operates a highly flexible global business model which helps to ensure a high degree of client awareness internally and client services externally.
The company is an expert in ad-hoc market research, both qualitative and quantitative with expertise in brand-development research and is solely active in the pharmaceutical and healthcare industry. They work extensively across all phases of the pharmaceutical lifecycle and have a strength in pre-launch and early phase market research.
The culture of the organization is open, supportive and non-political with an ambition to be regarded as the best and most innovative. You will work with highly motivated team members at all levels.
If you’re looking for long-term career advancement, the chance to stretch yourself, to grow and refine your skills, to contribute as an individual and part of a team, and to have what you do recognized and appreciated then we’d like to talk to you.
As the AE & Compliance Specialist, you ensure that the company is compliant with all relevant country-specific legislation; all professional codes of conduct/practice; rules and regulations of regulatory agencies including GDPR; and client-specific policies and procedures. Areas include, but are not limited, to: pharmacovigilance (AE reporting), incentive regulations and guidelines, privacy legislation, internal client approval processes.
Key Accountabilities and Responsibilities:
Ethical and Legal
Provide advice and support on ethical and legal responsibilities when conducting market research
- Use your knowledge of compliance-related legislation and client requirements to provide clear guidance and practical advice to the research team
- Help to define and implement processes and procedures to meet legal, regulatory and client specific requirements
- Review compliance-related aspects of agreements with clients; regulatory guidelines and updates; interpret and communicate information
Must be conversant with global data privacy requirements (GDPR specifically) and specific client privacy requirements ensuring all client requirements are adhered to and communicated throughout the company.
Provide support for regular audits against internal standard operating procedures (SOP) and industry standards to meet regulatory and client-specific requirements, including maintaining documentation and records.
To ensure compliance with client pharmacovigilance requirements, responsible for coordinating AE reporting across clients and internal training of employees
- Maintain an internal database for AE reporting
- Responsible for ensuring that AEs are correctly identified and reported in accordance with client specifications and market research codes of conduct
- Ensure that relevant staff is trained to correctly identify AEs according to client’s standards and client-specific procedures
- Train subcontracted fieldwork vendors when necessary
- Liaise with clients’ drug safety departments
- Ensure that records are maintained for possible audits (i.e., training logs, AE reports, reconciliations, etc...)
- Assist with the completion and timely filing of reports required by pharmaceutical companies
- Ensure that client follows all specific client AE documentation and regulation
Handle special requests including internal, client and independent audits by providing informational support to clients undergoing audits
Keys Skills and competencies required:
To effectively perform the duties, you must be able to demonstrate the following competencies that are essential to the position:
- Bachelor’s Degree plus 1-2 years of compliance/operations experience
- Ability to proactively identify and anticipate risk to the business in a complex environment
- Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
- Requires strong organizational and follow-up skills, communication and audit skills
- 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, PowerPoint and Outlook
- Strong project management skills
- Excellent oral and written communication skills
- Strong people skills – able to use appropriate persuasion to ensure that processes are follow
To discuss this interesting and unusual role in full then please contact mark on 0207 378 5476 or mark.leigh@suehill .com