PV Physician is outsourced by IQVIA to MNC pharma - it provides support to the China Affiliate Head of Patient Safety (AHoPS) and global team to ensure strong engagement within the business ensuring engagement and integration within the affiliate. Particularly, this position is involved in many aspects of pharmacovigilance coordination and execution at the affiliate for the pre-marketing drug development programs.

Position Responsibilities

• As a standing member of China Development Team (CDT), provide safety input on China development programs for assigned therapeutic area (TA) to protect patient safety and ensure compliance with regulations/company procedural documents.
• As a core member of regulatory submission team (RST) for assigned TA, contribute to China submission strategy, and prepare safety relevant documents for investigational new drug (IND) and new drug application (NDA) submission, including but not limited to briefing book/slide deck for authority consultation, protocol/protocol amendment, clinical study report, statistical analysis plan, clinical overview, integrated safety summary for Chinese population, product labeling, response to authority queries, etc.
• Author risk management plan (RMP) and lead the review/approval process in collaboration with relevant local and global functions; provide oversight of local risk minimization activities and materials as applicable.
• Provide expertise on product safety knowledge and patient safety position on safety matters.
• Maintain expert knowledge of local PV regulations/guidelines relevant to pre-marketing drug development programs, and provide interpretation and communicate impact of changes to global Patient Safety team and other applicable functions

• Offer safety training (e.g., product safety profile, safety strategy for drug development, etc.) to applicable staff.

Degree/Experience/Competency Requirements

• At least Bachelor's Degree in Clinical Medicine
• 3+ years' experience as PV physician for pre-marketing drug development programs in multinational companies
• Solid knowledge of pharmacovigilance and drug development
• Ability to make decisions independently and resolve issues appropriately
• Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
• Fluent in spoken and written English

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com