Senior Medical Director, Pharmacovigilance will drive and oversee the company's pharmacovigilance processes. The Senior Medical Director will participate in oversight of all post-marketing and clinical safety and pharmacovigilance activities. Will ensure timely, consistent, and accurate safety reporting in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs), and standard operating procedures (SOPs).
Oversee investigational and post-marketing regulatory reporting and pharmacovigilance activities for assigned products.
Medically review individual case safety reports from all sources for assigned products.
Oversee, prepare, and review Periodic/Annual Reports (FDA) and Periodic Safety Update Reports and other Benefit/Risk Update Reports (FDA and Global Regulatory Authorities).
Drive, prepare, and review responses to ad hoc regulatory queries, and signaling topic reports.
Develop and maintain state-of-the-art pharmacovigilance processes and procedures.
Oversee pharmacovigilance activities as a member of drug development project teams; lead Safety Review Teams.
Drive safety-related labeling activities for assigned products.
Participate in the management of PV vendor for safety database and case processing
Support MAA submission when needed
MD Degree required; Postgraduate training in a clinical discipline subspecialty preferred.
Hands-on clinical practice experience is desirable
A minimum of 7-10 years of Pharmaceutical Industry experience within the Drug Safety Department required.
Global drug safety experience required.
Strong knowledge of Periodic Safety Update Report (PSUR) and the ability to interface with international partners is required.
A working knowledge of ICH guidelines and global regulations and must be experienced in safety reviews of IBs, protocols, final clinical study reports, and summaries of safety is required.
Experience using a large-scale electronic data storage and retrieval system, required.
Ability to read, analyze and interpret scientific and technical journals.
Post-marketing and investigational event and aggregate assessment/review/ documentation skills; must have experience is writing/oversight of Annual Reports, PSURs, Type II Variations
Working knowledge of MedDRA coding and case series retrieval strategies.
Ability to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands
Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.
Ability to work with international collaboration partners and CRO's..
Must have very strong English language writing skills and mature verbal communication and presentation skills.