The Senior Drug Safety Data Reviewer works closely with the pharmacovigilance team to ensure data accuracy during the generation of pharmacovigilance deliverables, including data tables, summaries for safety evaluations and aggregate reports. The role will also have an administrative component supporting activities associated with the signal detection, risk management and safety governance process. The role ensures the creation of quality safety data described in safety documents and safety assessments of investigational or marketed products and supports the company's safety governance process.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Supports data accuracy and quality of specific safety deliverables (eg aggregate reports, safety analyses, RMPs) by working collaboratively with other pharmacovigilance team members according to specified timelines.
Identifies inconsistencies in medical and scientific data and offers possible solutions for resolution.
Ensures robust and consistent data accuracy and quality processes, procedures, and best practices on a continuous basis across Pharmacovigilance.
Manages assigned safety deliverables according to specified timelines to ensure timely delivery to internal and external stakeholders.
Contributes to assigned sections of safety deliverables (eg safety reviews, aggregate reports, investigator brochures).
Manages the signal management tracker for the company's products.
Provides administrative support for the safety governance process by organizing the Safety Management Team (SMT) and Executive Safety Committee (ESC) meetings, distributing materials and meeting outcomes (including minutes).
Ensures appropriate archiving of all safety documentation (including data sources and reports) independently to ensure good pharmacovigilance practices are met.
Creates safety data output from the safety database through our available business data extraction tool (by applying appropriate search strategies in collaboration with pharmacovigilance staff, and ensures accuracy of that data output
Performs medical/scientific literature searches and retrieves relevant literature for signal detection activities and aggregate reporting for investigational or marketed products.
Minimum of a Bachelor's degree with a healthcare certification or specified health care professional degree (i.e. RN, RPh, PhD, PharmD).
Candidates with a related science degree and requisite pharmacovigilance experience are also considered.
Prior experience in the pharma/biotech industry is not required, but prior experience within industry (incl drug development) would be an asset
Previous experience with drug development including the evaluation and interpretation of scientific and clinical data.
Excellent collaboration skills in a matrix environment to achieve common goals
Proven ability to meet strict deadlines; able to manage competing priorities and ability to be flexible and receptive to changing demands
Proven ability to follow instructions/guidelines, work independently and taking initiative
Demonstrated ability to handle ambiguity of source material by identifying medical and scientific data inconsistencies
Excellent attention to detail and accuracy and consistent high-quality standards
Excellent verbal and scientific writing skills
Strong experience in computer applications such as Microsoft Word, Excel, Microsoft Access, and Power Point, and a willingness to expand and increase competencies
Optional, but additional helpful skills:
Knowledge of database systems and data extraction tools (including safety database)
Knowledge of use of database dictionaries and search strategies
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.