London (Remote working initially)
Salary - Highly Competitive Six Figure Remuneration with comprehensive benefits package including Car Allowance, Bonus and Stock Options
As an exceptional Director of Pharmacoepidemiology, are you looking to join an agile business with a high profile in industry as a leading Biopharma company with global responsibility for a number of key therapeutic areas and the autonomy to build and develop a team with strategic oversight. This is a renowned organisation with rapid growth plans and long-term career opportunities. This is an exclusive role with Cpl Life Sciences and we are looking to engage with high profile candidates.
• Driving cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies. Generate epidemiology data to support clinical development and regulatory filings. Provide consultation as an in-house subject matter authority in epidemiology to other departments.
• Strategy and conduct of regulatory-agency required epidemiologic studies such as PASS, PAES, PMR, DUS. Evaluate the efficiency of REMS and RMMs in support of clinical development, regulatory filings, and post marketing requirements.
• As a subject matter authority, contribute to all pharmacoepidemiology activities.
• Working closely with Risk Management Leads, Regulatory Affairs and other functions, provide timely epidemiological and risk management support to project and product teams. This includes design, implementation and data analysis of epidemiological studies.
• Represent Pharmacoepidemiology on cross-functional teams, including Risk Management Task Force (RMTF), Safety Monitoring Teams (SMT), Clinical Study Teams (including with external partners), Safety Oversight Committee, and Independent Data Monitoring Committees.
• Proactively lead non-compound specific pharmacoepidemiology activities.
• Provide inputs to IIS studies and other epidemiologic consultation on epidemiologic studies to other departments.
• Actively participate in the development and maintenance of relevant SOPs and Working Instructions.
• Actively participate in process improvement activities within Global Product Safety.
Level of Experience required
• A PhD in Epidemiology, Pharmacoepidemiology, Statistics or Public Health and proven industry experience at a senior level
• Up-to-date knowledge of UK, US, EU, and international regulatory and pharmacovigilance requirements having previously work in a global role
• Function as a subject matter expert on epidemiology for assigned compounds.
• Experience utilizing automated healthcare databases (internal and large external databases) to support pharmacoepidemiologic activities. Have significant experience working with external vendors.