A Drug Safety Specialist is responsible for drug safety management such as conducting clinical trials, medical supervision, and keeping a tab on all applicable regulations and SOPs. Job duties listed on the Drug Safety Specialist Resume as – processing and writing of adverse event programs, following up on important case reports; serving as a link between a company and the patients or healthcare experts, conducting regular pharmacovigilance developments and supervising these processes, attending several meetings related to product safety, and adding value to the company through product safety functionality.
A bachelor’s degree in science, medical, healthcare, or nursing, or a Pharmacy degree from a reputed educational institute is required to apply for this job. Some companies may necessitate a specified degree also. Other skills also include – knowledge of clinical trial processes, a meticulous approach to work, and time management skills.
Objective : 5 years of Extensive experience in Drug Safety Specialist, Working knowledge of global regulatory requirements. Extensive experience with the processing of adverse events from clinical trials and post marketing surveillance. Knowledged of FDA guidelines, in-depth knowledge of ICH and GCP and Safety Reporting guidelines.
Skills : Clinical Trial, Argus, US-FDA, ICH, GCP, MedDRA, Aggregate Reports, MedWatch, CIOMS, Narrative Writing, Sound Medical Knowledge, Medical Review, Signal Detection, Protocol Review, Final Clinical Safety Report.
Description :
Synthesized and performed analysis on information received from a variety of sources and different adverse event report types ranging from clinical trials, spontaneous, literature, legal, and solicited.
Determined regulatory reporting requirements based on assessment of seriousness, causality and expectedness in accordance with regulatory and product labeling guidelines.
Evaluated case for SUSAR reporting, prepare SUSAR narrative draft, and regularly interacts with the principal investigator, research coordinator, clinical leads, and team physician to resolve any report queries or discrepancies.
Supported the Inspection Team during regulatory authority (FDA/EMEA) inspections and involved in the preparation of drafted responses.
Supported team-specific deliverables by generating daily lists of cases due, reviewing the comparator and/or blank list worksheet and notifying colleagues of cases that meet special reporting requirements.
Participated in database reconciliation during study closure and unblinding of clinical trials adverse event reports ensuring consistency of information between the study and safety database.
Supported company's outsourcing efforts by mentoring global colleagues (Shanghai and Mumbai) and vendor case reviewers in reviewing litigation, non-interventional study, and poison control cases.
Experience
2-5 Years
Level
Executive
Education
MS In Disaster Medicine
Drug Safety Specialist Resume
Headline : Seasoned Drug Safety Specialist with both small-large animal clinic experience, including hands-on care (office visits, hospital treatments, etc.) as well as surgery technician duties. Seeking to move back into the veterinary field from a long-standing career in the pharmaceutical research industry.
Skills : MS Office, Outlook, Drug Safety, Linux, GCP, Clinical research.
Description :
Reviewed adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance.
Assessed priority of cases i.e. Serious/Licensee Exchange/Non serious using medical judgment.
Involved in case processing including data entry, coding of medical information and writing narrative to summarize essential details of case.
Raised queries to safety responsible personnel for missing information.
Coded of the events and laboratory data using MedDRA dictionary.
Performed follow up from reporter to get the required details which can help to case completeness.
Performed quality control review of completed individual safety reports and ensure compliance with regulatory reporting requirements.
Experience
5-7 Years
Level
Executive
Education
MSc. In Clinical Research
Drug Safety Specialist Resume
Objective : Hardworking and self motivated professional with a diverse background in clinical nursing and the corporate environment. Seeking to obtain a position that promotes strengths which include organization, problem solving, leadership, collaboration and dependability. Computer skills include Word, Outlook, Excel and Power-Point.
Skills : Proficient In Microsoft Office, MedDRA Coding, Argus, ArisG.
Description :
Provided training to new staff for CFR's, ICH guidelines for good clinical practice and clinical safety data collection.
Recommended/dispensed drug therapy's for disease conditions.
Provided clinical overview of disease & condition along with proper medication use, treatment overdose, prevention of adverse reaction associated with drug regimen and providing proper guidelines for duration & specificity of routine check-up & follow up.
Communicated with clients to ensure compliance with safety and Pharmacovigilance SOPs.
Reconciled inconsistent and incomplete information reported on different reports related to investigational drug actively on clinical trials for a more meaningful case analysis as requested by panel experts.
Quality controlled of case reports, line listings, and tabulations.
Performed literature searches
Experience
2-5 Years
Level
Executive
Education
GED
Drug Safety Specialist Resume
Headline : About 5 years' experience in Pharmacovigilance, Regulatory Affairs and Clinical Data Management (CDM). Collecting source documents, and processed adverse event (AE) reports from clinical trials and post-marketing sources adhering to Standard Operating Procedures. Ensuring compliance with global and local procedural documents and local implementation of Clinical Drug Safety objectives, policies, processes and procedures and timely submission of safety reports.
Triaged, assessed, and performed data entry of adverse event (AE) and serious adverse event (SAE) information and Coding adverse events accurately using MedDRA.
Retrieved necessary data from Outcome Survey databases and/or Interact with the clinical team, medical monitors, investigative site personnel and sponsor representative for all initial and follow-up event information and query resolution.
Adversed event case processing and reporting requirements to ensure compliance with internal procedures, regulatory reporting requirements and contractual requirements with business partners.
Responsible for writing case narratives for Safety Database and for post marketing surveillance reports.
Performed case deactivations (JIRA) and maintaining Non-shire global safety database (Non-SGSS).
Provided case listing/line listing for PV-Scientists during preparation of PSURs and PBRER for the respective products.
Identified and requested appropriate follow up information on cases in consultation with the Medical Monitor and/or Drug Safety Physician, to ensure consistency of case entry and high data quality standards.
Experience
5-7 Years
Level
Executive
Education
Master Of Science
Drug Safety Specialist Resume
Objective : Highly qualified Drug Safety Specialist with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and I would excel in the collaborative environment on which your company prides itself.
Skills : Safety Specialist, MS Office.
Description :
Received clinical study Serious Adverse Event (SAE) reports, review for medical/regulatory content and assures accuracy per protocol requirements, obtain follow up as needed; ensure that all SAEs are complete prior to database closure.
Processed and distribute clinical study and post marketed SAE reports as per the company SOPs and country regulatory requirements.
Received, processes, and distributes spontaneous adverse event (AE) reports for marketed products, both serious and non-serious, as per the company SOPs.
Processed adverse event reports utilizing the ARISg safety database.
Completed AE/SAE reconciliation prior to clinical trial database closure Documented safety review plans for assigned clinical trials.
Interfaced with Quality Assurance, Medical Affairs, Regulatory Affairs, Medical Writing, Biometrics, and Clinical Operations.
Assisted with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested.
Experience
2-5 Years
Level
Junior
Education
Master Of Public Health In Public Health
Drug Safety Specialist Resume
Headline : As a Drug Safety Specialist, responsible for Entering data into Argus database using Med-DRA coding, case processing, preparing case narratives and assigning priority delivery times based on nature of drug and its urgency.
Skills : Training Skills, Time Managemnt.
Description :
Actively involved in drug safety processes for the Company's clients (Dr. Reddy's, Roche, Valeant, Promius) using the US-FDA drug safety reporting guidelines.
Communicated extensively with physicians and nurses, patients/ clients, via phone and fax and triaging to capture adverse events.
Collaborated with external groups such as CROs, FDA and GS.
Successfully faced 2 third party audits without a single finding regarding Medical/Safety documentation.
Involved in Serious Adverse Event processes and final Quality Assurance check when completed.
Initiated follow-ups on serious and applicable cases, thus ensuring high customer satisfaction.
Maintained local drug safety reporting requirements.
Experience
5-7 Years
Level
Junior
Education
MS
Drug Safety Specialist Resume
Summary : Drug Safety Specialist with over 7+ yrs of experience Proficient in data entry and excellent knowledge of ARGUS and ArisG safety databases Triaged every report to confirm the validity of the case and decide on the timelines in accordance with the regulatory requirements for submission and company specific standard operating procedures Good understanding of FDA regulations, MHRA, GCP/ICH guidelines and IRB documentation.
Skills : Planning Skills, Creative Skills.
Description :
Independently created a draft narrative of the event(s) based on the description of the case provided by the reporter, improve narrative content, use judgment to decide pertinent information to be included in the narrative adequately to concisely describe the nature and course of the event Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
Independently formulated pertinent follow up queries and provide guidance to the sites with safety reporting data, experience in preparing periodic reports.
Independently coded adverse events in MedDRA using clinical judgment and medications to WHODRUG Interacts on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues.
Participated in and oversight of all domain Safety client case processing activities Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet.
Independently assessed expectedness, seriousness, and causality in accordance with regulatory guidelines and product reference safety information Perform active follow-up via telephone contact with consumers and healthcare professionals, as needed Work with client Clinical Research, sometimes in Lead capacity, regarding information exchange and safety exchange agreements Ensure regulatory compliance with timelines for individual expedited case report submissions and provide assistance and timely delivery of information for aggregate reports, ad hoc report compilations, and other regulatory documents.
Interacted with client and other stakeholders for the purpose of safety data collection, data reconciliation etc.
Developed Expedited Reporting Procedures.
Experience
7-10 Years
Level
Management
Education
Bachelors
Drug Safety Specialist Resume
Headline : Responsible for managing, evaluating global quality complaints, documenting and providing AE and PQC related training feedback to registered nursing call center staff.
Skills : Nursing, Communication Skills.
Description :
Responsible for reviewing and managing all Adverse Event and Product Quality Complaint reports and associated documentation to ensure they have been accurately assessed.
Used Track- it to track and assure global adverse event forms were properly submitted to FDA.
Reviewed and analyzed AE and PQC narratives, and submit claims to FDA if necessary.
Tracked AE and PQC reports and ensure they are submitted within the specific timelines per FDA/ company/client Standard Operating Procedures.
Evaluated product quality complaints for seriousness or non-serious, creating and reviewing standard operating procedures.
Worked as a team member on improving processes, procedures and ad hoc projects for the Quality Control Department.
Provided advice in regulatory affairs.
Experience
5-7 Years
Level
Junior
Education
MS
Drug Safety Specialist Resume
Objective : Drug Safety Specialist with 2+ years of experience in Performing timely and accurate triage of adverse event reports, complaints inquiries from physicians, pharmacies, consumers, and sales representatives.
Skills : Sales, Managing Skills.
Description :
Responsible for the review, evaluation and management of adverse event reports from clinical trials and post-marketing sources.
Conducted triage of incoming cases to determine seriousness for prioritization of daily workflow and classify them according to regulatory reporting Determine expectedness against appropriate labeling list.
Reviewed all medical and drug terminologies according to project specific coding conventions, Investigator Brochure, Package Insert, and labeling list Review adverse event documents for accuracy, consistency, and completeness.
Generated follow-up letters to the reporter and/or associated HCP to clarify information for accuracy as well as capture additional relevant information.
Observed the conduction of periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies and assist in the preparation of aggregate reports.
Conducted peer quality review of case data to ensure quality and consistency of information.
Performed registration with relevant authorities for electronic reporting on behalf of the sponsor.
Experience
2-5 Years
Level
Executive
Education
Bachelor Of Pharmacy
Drug Safety Specialist Resume
Summary : Responsible for Conducting follow-up investigation and US regulatory reporting (MedWatch 3500) on all communications related to product safety/surveillance to complete needed AE information.
Skills : Planning Skills, Coordinating Skills.
Description :
Received, evaluated, and responded to inquiries related to product safety.
Responsible for assuring compliance with sops and FDA regulations for the reporting of adverse events to regulatory agencies.
Developed guidelines and insure the uniform and timely processing of adverse event reports.
Acted as a liaison internally and with external collaborators to develop programs and processes to meet the requirements of regulatory agencies.
Directed interaction with consumers and healthcare professionals who need product information and access support.
Collaborated with international staff to assure appropriate reporting (CIOMS) to all regulatory authorities.
Quality controlled of case reports, line listings, and tabulations.
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