Principal Auditor, Quality Assurance - Pharmacovigilance

At ICON, we have an incredible opportunity for an expert Principal Pharmacovigilance (PV) QA Auditor to join the team in our Sofia office or remotely.

As a Principal PV Auditor, you will be responsible for tasks assigned to the Quality and Compliance function such as internal audits, vendor audits, regulatory and sponsor inspections and defence audits and CAPA Management.

The Role

• Effectively plan and conduct PV QA audits (process, project and vendor) in order to assure that projects managed by ICON are of the highest standard and are in compliance with the requirements of relevant GVP regulations and other guidelines, ICON or Sponsor SOPs, and contractual requirements.

• Perform the role of a lead auditor to assess the effectiveness of the pharmacovigilance quality system and to verify that the quality system is being implemented.

• Become involved (depending on experience), when required, in audit risk management activities, staff training and contribute to the review of ICON systems and procedures as appropriate.

• Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.

• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

• Travel (approximately 10%) domestic and/or international.

• Have a thorough knowledge of all relevant GVP regulations and other guidelines.

• Perform contract audits for Sponsor companies as required.

• When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the applicable management on all QA issues, including audit planning and review of audit results.

• Assist with the development of the audit procedures.

• Train QA auditors and provide a benchmark of auditing competencies to less experienced colleagues.

• Assist with providing consultation of GVP regulations and guidelines to the organization, as required.

• Conduct induction/orientation of new staff in ICON quality policies and procedures.

• Assist with business development activities, including the preparation of cost proposals/contracts, and attend marketing presentation, when appropriate.

• Carry out a senior role in PV QA department, including supervision of relevant auditors and review of audit results.

• Assist with the management of the PVQA team when requested and authorized by the QA manager or higher.

What you need?

• Experience in Pharmaceutical and/or GVP environment including in-depth knowledge and experience in PV Quality Assurance auditing and/or with relevant regulatory compliance /Quality System.

• Thorough knowledge of relevant GVP regulations.

• Ability to review and evaluate safety-related data/records/systems/processes.

• Thorough knowledge of pharmacovigilance and clinical trial related safety activities.

• Thorough knowledge and experience in performing and leading Root Cause Analysis.

• Ability to manage complex issues and related CAPAs, including leading large cross functional teams, task prioritization, and project management as needed.

• Demonstrated coaching, mentoring & training skills, including the ability to give constructive feedback.

• Ability to work as part of a team.

• Highly developed problem solving skills, and the ability to resolve difficult situations.

• Well-developed interpersonal and communication skills (oral and written) with prior experience conducting presentations or facilitating meetings.

Why join us?

Because this is an excellent opportunity to maintain high-quality standards, plan and conduct rigorous PV inspections, which make a meaningful impact on healthcare worldwide.

Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

Ongoing development is vital to us, and as a Principal PV QA Auditor, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/colour/religion/sex/sexual orientation/gender identity/disability/vet/national origin.

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