Stephan Examitzki

Graduated Plan Officer Local Contact Person for Pharmacovigilance Deputy EU QPPV

Lead and manage domestic or international projects for Pharmacovigilance and Patient Safety Sponsor liaison, project assessment and initiation, resource planning, leading a cross-functional team, milestone planning and tracking Ensuring that projects are progressing according to contract and quality standards and SOPs Production of key project progress reports and evaluation of key performance indicators Therapeutic Area Expertise in oncology, cardiology, ophthalmology, pulmonology and psychiatry.

Functioning as a Medical Proposal Lead (MPL) for the provision of medical input into proposals, budgets and client Requests for Information (RFI/RFP) Appraising contracts for newly awarded projects within Medical and Safety Services Providing medical & pharmacovigilance (PV) subject matter expertise both internally and externally (e.g. client meetings), as required Working as medical representative on departmental and company-wide initiatives

Oversaw clinical trials and post-marketing projects in terms of Pharmacovigilance and Patient Safety Strategic input, including providing subject matter expertise, including costing, budgeting, resourcing, workflow and process design and analysis. Timely contribution to and strategic input and review of proposals (RFP) Support and/or lead internal and external audits and inspections and ensure that corrective actions are implemented as appropriate. Attend and lead internal and external meetings

SAE processing with maintenance of SAE databases, reconciliation, and ensured compliance with relevant regulations and Standard Operating Procedures (SOPs). Create and maintain project specific working files, case report files and project central files Participate in and lead client meetings / investigator meetings/ project specific training sessions

Processed credit and the performed within the modalities issued involving warned private credits and private bank accounts