Patient Safety Epidemiology Associate Director

Vertex Inc.•Boston, MA

2d•Remote

About The Position

The Patient Safety Epidemiology Associate Director leads safety and regulatory epidemiology activities for Vertex products across multiple therapeutic areas and throughout all phases of lifecycle. This includes execution of post-marketing regulatory study research strategies, leading comprehensive epidemiologic feasibility assessments, development of epidemiologic study designs, overseeing study implementation, interpretation of findings and communication to internal and external audiences.

Requirements

Specialized knowledge in pharmacoepidemiologic methods, pharmacovigilance regulations, and specific therapeutic areas
Specialized knowledge of study design methodology in general medicine and clinical practice, evidenced by experience in designing/implementation of epidemiology studies
Strong knowledge in pharmacovigilance guidelines and regulations
Excellent verbal and written communication skills, including experience with scientific presentations and peer-reviewed publications, to translate epidemiologic research methods and results to diverse audiences
Excellent independent decision-making skills
Strong project management skills
Proven ability to build strong collaborative relationships with stakeholders and business partners and to work effectively in a diverse matrix environment
PhD in epidemiology is required
Typically requires 5 years of experience in pharmaceutical/biotechnology industry, CRO, or academic setting or the equivalent combination of education and experience

Responsibilities

Major contributor and driver to the company safety risk management, signal detection, benefit/risk assessments, and post-marketing regulatory research strategies
Research the epidemiology of specific disease areas and events of interest, lead evaluation of data sources and data collection approaches, apply subject matter expertise in the design of observational studies, develop epidemiology sections for regulatory documents, and lead the post-marketing regulatory research strategy implementation
Effectively communicates safety and regulatory epidemiologic strategy to product teams
Leads all stages of the design and implementation of regulatory post-marketing studies: from feasibility assessments, development of study designs and protocols, and execution of studies, to communication and dissemination of results to internal and external (e.g., Regulatory Agencies, scientific communities) stakeholders
Contributes to company publications strategy via development of conference abstracts, presentations, peer-reviewed manuscripts based on the findings of epidemiological studies
Leads the development of epidemiology sections for Risk Management Plans (EU RMP, REMS, etc.) and other regulatory filings (NDA, PSUR, etc.) for products throughout lifecycle
Leads systematic and targeted epidemiologic literature reviews to support safety evaluation and / or post-marketing research strategies
Supports signal detection analyses of safety reporting system databases (FAERS, Vigibase) or other sources (e.g. Sentinel)
Leads study execution teams for post-marketing regulatory studies
Actively participates at strategic meetings including Disease Area Safety Teams and Global Patient Safety staff meetings
Collaborates cross-functionally to support company strategy for observational research, integrating innovative study methodologies
May supervise interns and / or contractors