ProClinical, in support of our client, are seeking an individual to fill the role of PV Auditor, based remotely in the USA. The successful candidate will provide Pharmacovigilance (PV) auditing services to external clients and to conduct contracted activities in accordance with contractual requirements, regulations, guidelines and Standard Operating Procedures.
- Plan, conduct, report and follow up contracted audits within agreed budget and timelines.
- Manage the fulfilment of assigned contracted activities; identify and escalate any potential out-of-scope activities.
- Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication.
- Keep abreast of current industry practices, applicable quality legislation and industry news.
- Remain conversant with SOPs and file documentation in accordance with filing requirements.
- Maintain a high level of organization and effective prioritization of workload.
- Ensure the security of confidential material at all times, and that Non-Disclosure Agreements ('NDAs') are in place before the release of any confidential information to third parties.
- Provide cover for colleagues during annual leave and other absences.
- Perform administrative tasks effectively and in a timely fashion.
Skills and Qualifications
- Degree in life sciences and thorough knowledge of PV and/or other applicable regulatory requirements.
- Strong written, verbal, and interpersonal communication skills, as well as fluency in the English language.
- Practical and enquiring approach to problem solving.
- Dedication to quality and reliability in all aspects of work.
- Responsiveness to customer needs and focus on customer satisfaction.
- Strong knowledge of Microsoft Office suite.
- Up to 50% travel as required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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