100% REMOTE - Pharmacovigilance Quality and Excellence
Quality in Pharmacovigilance Contractor
12 Month renewable contract
Support and drive discrete improvement projects relevant to the scope of the QPPV function.
- To provide support for maintenance of Pharmacovigilance System Master File (PSMF), Summary of Pharmacovigilance System (SPS) and PRAC monitoring activities.
- Provide project management support for dedicated project(s).
- SupportanddrivePV Excellence byinputtingtoadhoc allocated tasks in relation to:
- Developing and maintaining framework(s) for content quality measurement and oversight.
- Assessing the effectiveness of initiatives with identification of subsequent further improvement actions as needed.
- Developing standardised best practice templates, authoring instructions and guidance for production of Patient Safety outputs.
- Promoting and ensuring Patient Safety outputs are produced in accordance with High Performance Authoring (HPA) principles.
- Implementation of standards and skills with Patient Safety Therapeutic Area teams and individuals in close collaboration with Process Area Leads (PAL) and Process Owners (PO).
- Ensuring the adoption of standards and skills by developing and providing process competence and capability build training to functional groups within Patient Safety.
- Providing specialist knowledge and support to be recognized as experts and source of reference for safety teams and other stakeholders.
- Contribution to the definition and assessment of measurable objectives and delivery targets.
- Provide support for:
- Maintenance of Pharmacovigilance System Master File (PSMF)
- Summary of Pharmacovigilance System (SPS)
- Monitor PRAC outputs per SOP
- Provide project management support for dedicated projects
- Upon request participate and/or support activities for GVP audits/inspections
Education, Qualifications, Skills and Experience
- Health professional degree (MD, PharmD, RPh, RN, or related degree) or master's degree in life sciences, or related field
- Extensive experience in patient safety/pharmacovigilance including applicable industry experience and seen as a subject matter expert
- Extensive operational experience in production of core safety outputs
- Good knowledge and comprehension of relevant pharmacovigilance legislation
- Excellent medical writing skills
- Excellent communication skills
- Experience and ability to develop and implement new standards and best practices
- Strong project management skills
- Proven ability to lead teams and collaborate in a continuous improvement
- Regulatory strategy knowledge and experience
- Clinical development knowledge and experience
- Lean Sigma experience
Sthree US is acting as an Employment Business in relation to this vacancy.