The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes aggregate signal detection activities for selected products. This includes the development of signal detection strategy. In addition, this position will also support oversight of vendors.
The Safety Surveillance Physician (SSP) has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.
SSPs are responsible for the medical assessment of case level and aggregate safety data for new safety concerns and trends and the communication of these issues to the Medical Safety Officer (MSO) and the Safety Management Team (SMT). Additionally, SSPs participate in matrix management activities (Safety Management Team core member) and providing pharmacovigilance expertise on individual case reports and signal detection methods. SSPs support SMT activities such as evaluating safety issues, preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.
• PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. Describe those quantitative aspects of the position which reflect measures that are applicable to the position’s major responsibilities or end results. (TYPE BELOW THIS LINE)
• Medical evaluation of adverse event reports:
o Provide medical and patient safety support to therapeutic team for pre- and post-marketing programs
o Perform medical case review of serious individual case safety reports (ICSRs) and patient narrative, including review of source documentation as needed
o Perform medical review of serious ICSR coding
o Review seriousness, expectedness/listedness and causality of each event in the ICSR
o Review due diligence queries as needed and raise additional medical queries for pertinent information regarding ICSR
o Review watchlist cases as needed
o Write medical assessments for serious ICSRs
o Provide medical support for the Analysis of Similar Events (AOSE).
o Perform aggregate review of nonserious cases in line listings
o Evaluate ICSRs for potential product quality issues (including device malfunctions, if applicable).
o Identify potential signals and/or Designated Medical Events (DMEs) from ICSRs.
o Validate potential signals in signal tracking tool.
• Lead or participate as members of pharmacovigilance matrix-teams (i.e. Safety Management Teams) responsible for pharmacovigilance activities focused on individual products and therapeutic areas.
% OF TIME
• Participate in vendor oversight by providing training and knowledge transfer as required and developing a working relationship aligned within the governance framework.
• Lead process, technology and scientific innovations for SSP review and assessment, and reporting of adverse event data. Responsibilities include training activities, participation in selected reviews of aggregate reports such as PBRERs, PADERS, contributing to the development and implementation of risk minimization action plans, etc.
• Lead GMS Product Team to drive change, increase efficiency, effectiveness and quality, and foster alignment, across GMS and with key stakeholders. 5
• Identify and evaluate new safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports.
o Perform signal detection activities for selected products (including but not limited to real-time signal detection, interproduct data mining, and lot alerts).
o Perform validation of signals identified in reviews. Prepare summary analysis of safety data for the SMTs. Provide recommendations for further evaluation.
o Perform aggregate surveillance of spontaneous adverse event reports for potential product quality issues. 15
DECISION-MAKING AND PROBLEM-SOLVING: Describe the types of decisions which are made, reviewed or referred. Describe the types of problems solved or referred. Indicate the degree to which decisions made and problems solved are circumscribed by procedure, policies, standards, or regulations. (TYPE BELOW THIS LINE)
Decision making centers around applying a thorough understanding of international pharmacovigilance regulations, GMSO SOPs and policies and procedures. Identifying potential safety issues via single case review, aggregate signal detection methods and real time assessment of individual case safety review to identify potential safety concerns at the earliest stage possible to allow for the development of overall risk assessment strategies. A cornerstone of this process is the use of applied epidemiologic principles and computer-assisted tools to detect new safety signals from thousands of safety reports received per year. The initial decision will be to determine whether there exists a potential risk to the treated population and to prioritize identified signals for systematic review and analysis. Based on a review of characteristics of a small series of cases, or based upon a statistical disproportionality compared to other drug/AE combinations, selected issues will be discussed with the Medical Safety Officer. The SSP will function at a high level of independence and must be prepared to represent the function and make decisions about the appropriate course of action to take when confronted with specific issues. Examples may include changes to the safety sections of investigator brochures, developing plans for targeted monitoring of selected safety issues as part of surveillance and/or Risk Management Plans and representing GMS on internal and external committees.
REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides.
This position reports to the Director, Team Lead SSP.
WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature.
Medical Safety Officers – frequent. Discuss findings from ICSR review/AOSE/DME and/or systematic surveillance program and suggest potential safety issues for further evaluation. Provide surveillance consultation on ad hoc safety issues and queries. Participate with Medical Safety Officers on preparation of Pharmacovigilance Plans or Risk Management Plans.
Aggregate Reports Group- occasional. Discuss signal detection findings and suggest potential safety issues for discussion in PBRER and other regulatory reports. Suggest potential search and analysis strategies for case series of interests.
Support Desk – occasional. Suggest potential search strategy to identify case series of interests.
Safety Associates frequent. Reviews the AE reports prepared by the Safety associates and amends as needed. Requests specific follow-up information on cases. Ensures that the Safety associates are kept informed of product-specific information, such as labeling changes, new protocols, or potential safety signals.
SSP frequent. Ensure bi-directional flow of product-specific information via participation in extended therapeutic team meetings, product-specific meetings, AOSE summaries, Ad-hoc emails/telecons.
Methods and Analysis – occasional. Ongoing evaluation of systems, tools and methodologies for aggregate data analysis and signal detection.
EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.
Medical degree from a recognized medical institution. Board Certified/Board Eligible/equivalent or 2 years post-graduate training or combination of 5 years of post-graduate training in a recognized medical specialty plus clinical medical experience is acceptable.
An unrestricted medical license or equivalent or eligibility in one of the territories of GMS operations required.
Familiarity with pharmaceutical industry principles of drug development and pharmacovigilance is preferred but not required.
Sound knowledge of general medicine and clinical practice, and the ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential. Good communication skills (written and verbal) and the ability to work in a team-oriented, matrix environment are necessary. Significant experience and judgment required to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio.
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