Compliance Specialist - Pharmaceutical Company

1 jour restant

Région
Walloon Brabant
Salaire
Negotiable
Publication
mardi 22 août 2017
Date limite
vendredi 22 septembre 2017
Réf
555791/001
Contact
Charles Jean
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
  • Compliance Specialist
  • Pharmaceutical Sector

Client Details

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.

Description

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.

Profile

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;

Job Offer

As a Compliance Specialist you will have an attractive salary package in line with your experience.