Compliance Specialist - Pharmaceutical Company
- Compliance Specialist
- Pharmaceutical Sector
Our client is one of the major biopharmaceutical company with large offices in Belgium.
To sustain their growth they are looking for a new Compliance Specialist to join the "Global Quality & Regulatory Compliance, Clinical Trials & Safety" team.
As a Compliance Specialist you will be part of an international team that is responsible for:
- Auditing all processes related to clinical research including specific medical affairs processes, and pharmacovigilance activities;
- Assessing compliance with relevant regulations and applicable policies and procedures. This includes investigator site, internal systems and external vendor audits;
- Being responsible for management of regulatory agency inspections and for providing advice on regulatory requirements.
As a Compliance Specialist you will have the following responsibilities:
- Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internal systems and clinical study reports to assess regulatory compliance;
- Apply audit principles, procedures, and methods; Prioritize and focus on matters of significance;
- Collect information through effective interviewing, listening, observing and reviewing documents, records and data;
- Confirm the sufficiency and appropriateness of audit evidence to support audit findings and conclusions;
- Assess those factors that may affect the reliability of the audit findings and conclusions; Perform and document analyses of audit findings where indicated;
- Prepare clearly-written, concise, accurate and evidence-based audit report; Maintain audit database;
- Review and assess received corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence.
- Maintain an in-depth knowledge of governmental regulations impacting clinical research and PV and development of medicines.
- Provide advice and counsel concerning GCP regulatory requirements.
- Act as project-specific liaison (Project Coordinator) and provide input into audit plans. Regularly evaluate key PV and clinical research processes to determine compliance with regulatory requirements and established standard operating procedures.
As a successful Compliance Specialist will fit the following requirements:
- University graduate, Life Sciences degree preferred
- Demonstrated expertise and specific technical knowledge of the GCP and PV areas subject to audit, as evidenced by at least 4 years in the pharmaceutical industry or equivalent.
- Minimum 2 years technical auditing or equivalent; PV and GCP auditing preferred.
- Computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication;
- Good understanding of the drug development process;
- Excellent oral and written communication skills;
- Fluent in English,any other languages are a plus;
- Commitment to delivering high-quality work product;
- Strong critical thinking to analyze complex situations and discern critical issues and non- compliant situations and to recommend appropriate corrective and preventive actions;
- Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective; Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;
- Develops strong working relationships with key stakeholders;
As a Compliance Specialist you will have an attractive salary package in line with your experience.