Senior Safety Scientist, Aggregate Reports GPV-US - United States
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- The Senior Safety Scientist, Aggregate Reports GPV-US provides the scientific and analytical support for the Pharmacovigilance function of aggregate reports.
- This position is responsible for signal evaluations and reporting activities that provide the basis and analysis for potential labeling changes to the reference safety information.
- Provides expertise as a scientist in area of signal analysis and is adept at interpretation of statistical methods, application of epidemiologic principles and evaluation of data generated from published medical literature and internal and external databases.
- Translates scientific information into summaries for action on potential signals.
- Works closely with the pharmacovigilance medical directors and provides supplemental scientific information to determine validation of signals.
- Contributes to the overall assessment of benefit/risk analysis from risk characterization of both marketed and products under development through surveillance and signal detection activities.
- This position reports directly to the Senior Director, Risk Management & Aggregate Reports GPV-US.
- Compiles and analyzes safety data for inclusion into aggregate reports and safety analyses; evaluates impact to benefit/risk in conjunction with medical director(s)
- Proactively investigates trends in safety data and follows scientific methodology and logical reasoning to determine cause/effect and potential prevention of adverse events. Reports findings to management and assigned medical director
- Evaluates signals using available signal tools including use of external epidemiological databases, review of scientific literature and pharmacovigilance safety data. Considers impacts to benefit/risk assessment and risk characterization and incorporates into relevant documents (i.e. PBRER, RMP)
- Ensures timely communication of potential safety signals through surveillance activities to line management
- Conducts analyses within the aggregate reports group with a systematic scientific approach which allows for a consistent review of all products using the same methodology
- Collaborates with PV Medical Directors, Safety Surveillance, and Safety Systems on all activities to support preparation of aggregate reports, risk characterization and signal detection
- Leads coordination of signal assessment activities with Safety Committee members including compiling source data, scientific interpretation and presentation of data for analysis
- Leads efforts in strategy & research of literature and drug databases and compiles source data for aggregate review in evaluation of signals
- As subject matter expert, prepares and presents safety data to management and company’s Safety Committee
- Collaborates with cross-functional teams and provides safety information to assist in labeling review and safety committee review meetings
- Ensures expertise is pharmacovigilance and scientific area by keeping current and communicating information from relevant scientific literature, regulations, courses and conferences
- Manages and tracks signal detection activities collaborating with medical directors to accurately track open, refuted and closed signals and documentation of important and potential risks for continuity of safety surveillance activities
- Contributes in the review of the overall safety profile and risk/benefit profile of marketed products and drugs in development at specified intervals per SOP
- Ensures regulatory compliance by providing timely, quality information for aggregate reports and signal review following SOPs and regulations
- Monitors report deliverables/timeline working with cross functional groups and adjusts project timeline accordingly
- Contributes to the development of standard operating procedures and pharmacovigilance processes for aggregate report and signal detection activitie
- Bachelor’s degree in Health Science, Pharm D, Nursing or related healthcare degree
REQUIRED SKILLS AND EXPERIENCE:
- 5+ years of experience in one or more of the following areas; pharmacovigilance, clinical research, medical affairs or medical writing.
- Knowledge of regulations and guidance (US and global) governing pharmacovigilance practices
- Ability to analyze safety data in aggregate from multiple sources
- Sound understanding of pharmacovigilance safety surveillance activities
- Expertise with critical appraisal of scientific medical literature
- Working knowledge of MedDRA
- Proven ability to produce aggregate safety reports (PSUR/PBRER, DSUR, signal evaluation reports)
- Ability to work well with minimal supervision in a fast-paced environment
- Excellent medical/technical writing skills
- Strong oral and presentation skills
- Experience with Microsoft Office applications
PREFERRED EDUCATION, SKILLS AND EXPERIENCE
- Graduate degree in health sciences, Public Health
- Knowledge/experience with safety database and use of external databases such as FOI, Vigibase
- Project management experience beneficial
- Willingness to travel up to 10% domestically. International travel may be required.