Senior Pharmacovigilance Compliance Specialist
An exciting opportunity has arisen for a Senior Pharmacovigilance Compliance Specialist to join a global biopharmaceutical company based in London. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
- You will undertake and coordinate the planning, conduct, and follow-up of internal and external audits, including audits of internal processes, vendors (e.g. CROs) and distributors/partners.
- You will collaborate with internal and external staff in the conduct of audits.
- You will maintain knowledge of pharmacovigilance regulations and company standard operating procedures for pharmacovigilance.
- From time to time you will be expected to assist with activities for other GxP compliance programmes, and as such you will be required to develop knowledge in these areas.
- You will help foster a commitment to quality and compliance within the organization and provide guidance on interpretation and application of existing and new PV regulatory requirements to R&D Quality and Compliance management.
- You will assist with the review and optimization of R&D Quality and Compliance processes and with the training on written procedures.
- You will assist with the preparation and facilitation of regulatory agency inspections.
- Leads others in all types of internal or external routine audit activities and document reviews.
- Able to lead more complex audit activities.
- Assists in identifying, defining and communicating audit plans and assembling information for contract auditors.
- May assist in ensuring contract auditors are trained in company procedures.
- May assist in development of departmental SOPs.
- May participate in the review of business area SOPs.
- Contribute to or leads study management teams, intra- and interdepartmental complex project teams.
- Provides support during regulatory agency inspections.
- Participates in developing and presenting training using standard modules and training on special topics.
Skills and Requirements:
- A BSc degree or an MSc in a scientific discipline with relevant experience in the pharmaceutical quality control, quality assurance or compliance environment, consistently meet standards required in Compliance.
- A working understanding of regulatory requirements, including global PV requirements and regional requirements for assigned territories.
- Good verbal, written and interpersonal skills are required.
- Prioritizes work independently to meet tight timelines.
- Must have a very good attention to detail and demonstrate the ability to consistently meet the high standards required in Compliance deliverables.
- With minimal guidance, determines efficient and/or appropriate methods of communication.
- Ability to consistently discern area(s) requiring input from a senior Compliance professional.
- Must have a full working knowledge of regulatory requirements for assigned territories.
- Seeks to have understanding of current global and regional trends in regulatory compliance.
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 Kevin Hansberry on +44 207 4400 636 or upload your CV 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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