Drug Safety Physician Resume
Objective : As a Drug Safety Physician, responsible for coordinating with various lateral and subordinate office chiefs to address matters pertaining to prioritization of projects and equipment, informatics policy, and any phase of the Clinical Systems Integration programs.
Skills : Medical Knowledge, Pharmacovigilance Expertise.
Description :
- Led safety evaluation for designated products including signal detection and analysis and safety reporting.
- Provided safety expertise to international project teams.
- Performed medical screening for potential participants to ensure they met the medical requirements of the study.
- Reviewed and evaluated Vital Signs, ECGs, Spirometry, Holter, and Laboratory test results.
- Responsible for administratively directing and coordinating the activities of medical staff personnel.
- Reviewed and analyzed Clinical System Integration work methods and operational procedures and made changes based on findings.
- Ensured data quality and evaluation of system performance metrics and reporting.
Experience
0-2 Years
Level
Entry Level
Education
Medical Degree
Drug Safety Physician Resume
Summary : As a Drug Safety Physician, responsible for evaluating and assessing the safety and efficacy of drugs, both before and after they are approved for use by the general public.
Skills : Data Analysis, Communication.
Description :
- Served as a presenter at national, regional, and local conferences on informatics best practices.
- Identified and assessed safety risks associated with drugs, and made recommendations for managing or mitigating those risks.
- Communicated safety information to regulatory agencies, healthcare professionals, and the general public.
- Participated in the development of risk management plans, which outline strategies for minimizing the risk of adverse events associated with drugs.
- Reviewed and approved protocol for clinical trial safety and contributed to the report of clinical trial safety.
- Stayed up-to-date with the latest developments in drug safety, including new regulations and guidelines, to ensure that safety evaluations are conducted in accordance with the latest standards.
- Provided drug safety support when appropriate for product acquisitions and legal issues.
Experience
10+ Years
Level
Senior
Education
MD
Drug Safety Physician Resume
Summary : As a Drug Safety Physician, responsible for collaborating with other members of the drug development team, including pharmacologists, toxicologists, and statisticians, to ensure that safety issues are adequately addressed.
Skills : Problem-Solving, Medical Coding.
Description :
- Reviewed and evaluated the safety and efficacy of new drug candidates during the development and approval process.
- Participated in the design and conduct of clinical trials to ensure that safety and efficacy data are collected and analyzed appropriately.
- Contributed to the preparation of regulatory submissions and responding to questions from regulatory agencies regarding the safety and efficacy of drugs.
- Participated in ongoing safety surveillance programs to monitor the safety of drugs once they are on the market.
- Responsible for the overall safety of the drug, from preclinical development to post-approval.
- Completed all departmental project activities accurately in accordance with SOPs, Project Specific Procedures, regulatory requirements, and client processes.
- Provided medical review of safety events (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project-specific procedures.
Experience
7-10 Years
Level
Management
Education
Medical Degree
Drug Safety Physician Resume
Objective : As a Drug Safety Physician, responsible for collaborating with other departments within the company, such as research and development, regulatory affairs, and marketing, to ensure that safety and efficacy data are communicated effectively to internal and external stakeholders.
Skills : Regulatory Compliance, Risk Management.
Description :
- Provided input and reviewed relevant safety information for signal detection and risk management activities.
- Performed safety review of clinical and diagnostic data as part of case processing and aggregate reporting.
- Provided medical review of aggregate reports (PSUR, PBRER, DSUR, and ASR).
- Served as the main pharmacovigilance/safety physician point of contact for the customer for the life-cycle of assigned projects.
- Assisted in the preparation and conduct of code-break activities.
- Provided input and consultancy to the client in the course of generation of the Company Core Data Sheet/Core Safety Information and Product Information.
- Guided Pharmacovigilance and Safety Services staff about the regulatory reporting of adverse events.
Experience
2-5 Years
Level
Executive
Education
Medical Degree
Drug Safety Physician Resume
Objective : As a Drug Safety Physician, responsible for providing medical expertise and guidance to other members of the company, such as sales and marketing teams, to ensure that the appropriate safety information is communicated to healthcare professionals and patients.
Skills : Strong clinical background, Case report analysis and review.
Description :
- Assisted with the generation of project-specific procedures (medical review workflow activities).
- Liaised with the investigational site, reporter, and/or client as necessary regarding safety issues.
- Liaised with the Medical Monitor, project manager, and other departments, as appropriate.
- Reviewed and approved protocols and other miscellaneous study documentation and identified potential product safety problems.
- Performed medical review of Analysis of Similar Event (AOSE) reports.
- Prepared and reviewed periodic aggregate safety reports and development Safety Update Reports (DSURs) from aggregate data for assigned products.
- Developed safety monitoring and reporting plans for clinical studies and ensured the quality of medical program deliverables in accordance with quality assurance project plans and standards.
Experience
0-2 Years
Level
Junior
Education
Medical Degree
Drug Safety Physician Resume
Summary : As a Drug Safety Physician, provides medical oversight and completion of analysis of similar events, company causality assessment, expectedness assessment, review of MedDRA coding, signal detection, risk management, and pharmacovigilance oversight for assigned projects.
Skills : Understanding of drug development, Time management.
Description :
- Performed Signal detection activities and evaluation including preparation of Signal Management Reports.
- Provided medical, scientific, and therapeutic expertise on pharmacovigilance services.
- Composed, edited, and medically reviewed Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
- Served as an internal consultant to pharmacovigilance case processing teams on projects being supported.
- Provided aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile.
- Provided coding review of AEs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data.
- Represented safety and clinical data review findings during client meetings.
Experience
7-10 Years
Level
Consultant
Education
MD
Drug Safety Physician Resume
Summary : As a Drug Safety Physician, provided an assessment of safety issues arising in clinical trials or in the post-marketing setting escalated those to the project manager, and discussed the agreed approach to resolution with the client.
Skills : Integrity, Knowledge of clinical trial processes.
Description :
- Provided medical oversight for label development, review, and change.
- Provided medical support and attendance at Data Safety Monitoring Board Meetings.
- Attended and contributed to medical safety evaluation on Safety Monitoring Committees.
- Attended project meetings, medical safety team meetings, and client meetings as requested.
- Ensured coverage for all medical safety deliverables within regulatory or contracted timelines.
- Provided medical escalation support for medical information projects.
- Provided medical escalation support for EU Qualified Persons for Pharmacovigilance projects.
Experience
10+ Years
Level
Senior
Education
Medical Degree
Drug Safety Physician Resume
Objective : As a Drug Safety Physician, performs medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary.
Skills : Medical ethics, Human anatomy.
Description :
- Maintained awareness of medical safety-regulatory industry developments.
- Reviewed and analyzed adverse event reports, clinical trial data, and other safety information related to drugs.
- Monitored and reviewed safety data from clinical trials and post-marketing surveillance, identifying potential safety concerns and trends.
- Developed and implemented risk management plans.
- Communicated safety information to healthcare professionals and patients.
- Prepared and submitted periodic safety reports to regulatory authorities in compliance with regulatory requirements.
- Conducted review and assessment of individual case safety reports obtained from clinical trials, and spontaneous and solicited reports.
Experience
2-5 Years
Level
Executive
Education
Medical Degree
Drug Safety Physician Resume
Summary : As a Drug Safety Physician, performs medical, safety monitoring, or pharmacovigilance activities for assigned projects. Contribute to and provide medical review, analysis, and guidance in all required safety reports.
Skills : Pharmacology, Treatment planning.
Description :
- Performed triage of cases and determined seriousness and relatedness across products as assigned.
- Reviewed and verified appropriate selection of adverse events from source documents, assigned appropriate MedDRA code, assessed labeling, and reviewed narrative.
- Acquired and maintained current knowledge of product portfolio and safety profiles for products across therapeutic areas.
- Escalated complex case issues on client product(s) to the medical review team of the client as appropriate.
- Conducted assessment of litigation cases across products as assigned.
- Identified and resolved case issues, and coordinated with client therapeutic teams/sites for specific products or functional groups.
- Communicated and interacted effectively within and across all client therapeutic teams, and within functional team management as appropriate.
Experience
7-10 Years
Level
Management
Education
Medical Degree
Drug Safety Physician Resume
Summary : As a Drug Safety Physician, responsible for safety surveillance activities for this product including medical review of individual safety cases directly in the safety database and signal detection activities.
Skills : Case processing, Clinical research.
Description :
- Acquired and maintained knowledge of applicable Global Health Authority regulations.
- Evaluated and established the safety profile of this product in collaboration with the different company experts and/or partner vendors.
- Provided expert safety input to the clinical development program, study documents such as study protocols, informed consent, investigator brochures, and Development Safety Update Report.
- Escalated and presented safety issues at company safety governance bodies.
- Ensured the oversight of medical activities outsourced to our PV vendor.
- Generated medical queries to sites for clinical trial cases.
- Provided medical advice to safety scientists to assist them with the processing of ICSRs.
Experience
7-10 Years
Level
Consultant
Education
Medical Degree
