Assistant Director, Affiliate PV Partner Compliance
ProClinical is currently seeking an Assistant Director for a biopharmaceutical company located in North Chicago, IL. Successful candidate will establish and maintain effective oversight and invoicing controls of external providers of pharmacovigilance services affiliates.
- Monitoring of supplier performance via SLAs and other metrics, preparing routine and ad hoc reports, owning the investigation of trends, and escalating issues as appropriate.
- Overseeing quality control of all outsourced processes and reliable documents results. Refining and adapting QC approaches to account for external and internal process, regulatory and business change.
- Owning issue investigation, coordinating between teams and supplier systems.
- Collaborating with suppliers and internal partners to implement vendor compliance management processes which integrate with supplier and processes wherever possible.
- Supporting the use of risk-proportionate approaches for in-line and retrospective evaluations.
- Owning the managing and tracking of all invoicing activities for all outsourced PV affiliate activities for each affiliate worldwide.
- Supporting the establishment of quality management processes for external suppliers of affiliate pharmacovigilance services that meet applicable PPS, RDQA, and affiliate standards and ensure reproducible, controlled, and timely delivery of high-quality outputs.
- Owning the development of training plans and supporting delivery of training sessions in conjunction with supplier.
Skills and Requirements:
- BS or equivalent in related science field.
- 5-7 years pharmaceutical industry experience; including 5+ years in pharmacovigilance, vendor management and/or training operations. Affiliate experience strongly preferred.
- Strong knowledge of global pharmacovigilance requirements, including regulations and affiliate environment, with a firm understanding of related quality assurance systems.
- Experience in health authority inspections and/or internal or third-party audits.
- Highly skilled in data interrogation and interpretation; highly experienced with using complex models and excel.
- Able to influence across multiple stakeholders and manage within a cross-functional matrix; seen as a collaborative partner at all levels of the organization.
- Able to proactively identify, rapidly assess, and effectively manage business and compliance risks.
- Strong end to end knowledge of outsourced PV processes, invoice management and working with Vendor's supplying global pharmacovigilance services.
- Excellent oral and written communication skills.
- Proven track record of managing Vendor invoicing activities.
- Occasionally willing to travel.
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.
Highly Competitive Salary
ProClinical, in support of our client, are seeking an individual to fill the role of PV Auditor, based remotely in the USA.