Medical Director

Description:

Provides medical review and analysis of pre-approval serious adverse events, post-approval ICSR and periodic safety reports as well as other client deliverables (labelling reconciliation documents, CTD modules, REMS, RMP and CSR) to ensure company SOPs, client directives, and regulatory requirements are followed. Other responsibilities may include attending and presenting at investigator and sponsor meetings, providing medical consultation to clients, investigators and project team members and support business development activities. Medical Directors also serve as mentors to PVG colleagues.

Education And Experience

• MD degree or equivalent
• Active medical licensure (preferably in country of residence)
• Several years of relevant experience such as pharmaceutical industry or CRO, in clinical development or pharmacovigilance or significant clinical trial experience as a principal investigator, and experience treating patients in a clinical setting.

Knowledge, Skills And Abilities

• Must be board certified or equivalent in Endocrinology.
• Fluent in spoken and written English
• Strong medical knowledge
• Expert knowledge regulations governing adverse event reporting
• Understanding guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
• In-depth understanding of processes for medical monitoring services; ability to represent these processes at client meetings and identify any non-standard processes, and to identify any services out of the scope of the contract
• Understanding biostatistics, data management, and clinical operations' procedures
• User level computer application knowledge (Microsoft Word, Excel, PowerPoint, Adobe Acrobat, etc.)
• Ability to mentor effectively on global medical processes in both one-on-one and in group settings.
• Overall knowledge of the drug development process