Drug Safety
Careers Integrated Resources Inc
Drug Safety
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
Case Processing: 75% of time Definition: The completion of full case information on the database, culminating in Quality Review to ensure accuracy and completeness. Activities Include:
- Triage of incoming cases to determine seriousness for prioritization of daily workflow (to be discussed re triage specialist)
- Confirmation of Safety Coordinator case registry data
- Database searches as necessary
- Completion of literature searches as necessary
- Completion of remaining case data entry, including narrative or auto-narrative
- Completion of risk and quality (label, approval, manual coding & quality review steps)
- Clarification of unclear or illegible information from the LSO or Call Centre
- Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician
- Completion of protocol request forms as necessary
- Preparation of deviation memo as necessary
- Request deletions as necessary
- Single case unblinding
- Standard Operating Procedures and Working Practices
- Department guidance documents
- MedDRA coding dictionary and MedDRA points to consider
- Understand relevant safety implications regarding contracts with operating companies and/or marketing partners
- Review and make suggestions for system and procedure enhancements
Processes and Procedures: 5% of time Definition: Continuing awareness of company procedures and guidelines to maintain regulatory compliance. Activities Include:
5% of time = Project Work, Audits, Inspections and other Ad-hoc
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Drug Safety in Horsham, PA vacancy
- ...Drug Safety Associate I Responsible for the receipt and data entry of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate...SuggestedContract workLocal areaWorldwide
Integrated Resources
Horsham, PA1 day ago - ...expedited and periodic reports. Provides integrated strategic safety expertise to clinical developments. Performs active... ...identification and analysis of safety signals, to define emerging drug safety profiles of all products and drive patient risk management...Suggested
Integrated Resources
Horsham, PA1 day ago $25 - $35 per hour
...assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant... ...No degree required Physical Requirements About Safety Assessment Charles River is committed to helping our partners...SuggestedContract workLocal areaWorldwideFlexible hoursCharles River
Horsham, PA2 days ago$128.96k
...Pharmacist you will: Evaluate physician medication orders for drug appropriateness, correct dosage, potential drug interactions,... ...of practice Knowledge of drug therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA)....SuggestedFull timeLocal areaMonday to FridayFlexible hoursShift workWeekend workBrightSpring Health Services
Warminster, PA3 days ago- A leading compliance and pharmacovigilance firm is seeking a Compliance Analyst / Drug Safety Case Processing in Horsham, PA. The successful candidate will be responsible for developing compliance metrics, ensuring quality control, conducting User Acceptance Testing, and...Suggested
$5,000 per month
...Pharmacist you will: Evaluate physician medication orders for drug appropriateness, correct dosage, potential drug interactions,... ...of practice Knowledge of drug therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA). Proficiency...Full timeMonday to FridayFlexible hoursShift workWeekend workAfternoon shiftBrightSpring Health Services
Horsham, PAa month ago$5,000 per month
...pharmacist you will: Evaluate physician medication orders for drug appropriateness, correct dosage, potential drug interactions,... ...of practice Knowledge of drug therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA). Proficiency...Full timeMonday to FridayFlexible hoursShift workWeekend workDay shiftAfternoon shift$180k - $200k
...industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life‑saving... ..., skills, education, certifications, and location. About Safety Assessment Charles River is committed to helping our partners expedite...Contract workLocal areaRemote workWorldwideFlexible hours- ...Strategy and Analytics and is responsible for development and delivery of Global Medical Organization (GMO), Office of Consumer Medical Safety (OCMS) and Dual-sector medical safety procedural documents. The Senior Associate, PV Documents is responsible for assigned...Permanent employmentWork at officeWorldwide
$87.3k - $137.4k
...cancer, cardiometabolic diseases, Alzheimer’s disease and infectious diseases including HIV, COVID-19, and Ebola.The Nonclinical Drug Safety group is seeking a highly motivated individual with strong technical skills and attention to detail to join the Toxicology Operations...Full timeFor contractorsInternshipWork at officeLocal areaMonday to Friday- ...Pharmacovigilance Scientist The Scientist role is primarily responsible for aggregate safety analyses and aggregate report writing. He/she will contribute or will be responsible for report writing and/or report ownership related to core safety deliverables including...
Integrated Resources
Horsham, PA2 days ago - Une entreprise de recrutement reconnue dans le secteur de la santé recherche un responsable qualité et conformité en pharmacovigilance. Le candidat idéal aura un diplôme pertinent et plusieurs années d'expérience dans l'industrie, ainsi qu'une expertise en développement...
$96.2k - $151.4k
Position Description Within the dynamic environment of Nonclinical Drug Safety (NDS), a Specialist in Information Management works with internal scientific staff and across our Research & Development Division to coordinate, assemble, and manage regulatory documents for...For contractorsWork at officeRelocationVisa sponsorshipFlexible hoursShift work$106.2k - $167.2k
Job DescriptionThe Nonclinical Drug Safety (NDS) division at our company is seeking a motivated and talented biomedical engineer or integrative systems scientist with experience in signal processing and/or computational modeling using physiologic signals to join our Safety...Full timeFor contractorsLocal area- A leading data analysis firm in Horsham, Pennsylvania, is seeking a Scientist to be responsible for aggregate safety analyses and report ownership related to core safety deliverables. The role involves preparing scheduled and ad-hoc safety reports, conducting safety analysis...
- ...requested line listings Assist in the reconciliation of clinical and safety databases Contribute to the preparation and quality control of... ...Pharmacovigilance (PV) reporting experience with drugs and biologics; experience with safety surveillance of vaccines and...Permanent employmentContract workFor contractorsLocal areaWork from home
Mindlance
Blue Bell, PA4 days ago - Merck in the United States seeks an Associate Vice President, Therapeutic Area Head (TAH) to provide strategic leadership for clinical safety assessment and risk management across multiple therapeutic areas, reporting to the Vice President of CSRM. This role oversees...
- Merck & Co., Inc. is seeking a dedicated scientist to join the Toxicology Operations group within Nonclinical Drug Safety. The role involves conducting in vivo safety studies ranging from acute to chronic, following GLP and OECD guidelines, and contributing to data-driven...
- Merck & Co., Inc. in Rahway, NJ, is seeking a detail-oriented Toxicology Operations specialist to join the Nonclinical Drug Safety team. The role supports in vivo safety studies under GLP and OECD guidelines to advance drug development. You will perform dose administration...
- ...GLP-compliant protocols. The role requires cell culture expertise, strong communication, and collaboration with theNon-clinical Drug Safety team. Education includes BS or MS with 3+ years of experience, with a focus on biology or related sciences. #J-18808-Ljbffr MSD...
- Merck & Co. seeks a Specialist in Information Management within Nonclinical Drug Safety to coordinate, assemble, and manage regulatory documents for internal studies and external efforts. The role supports PCD operations in Veeva and crafts internal processes to optimize...
$87.3k - $137.4k
...DescriptionLaboratory Scientist, Genetic ToxicologyWe are seeking a laboratory scientist to join the Genetic Toxicology group within Non-clinical Drug Safety. This individual will be part of a high performing group and primarily responsible for the conduct of in vitro genotoxicity...Full timeFor contractorsLocal areaFlexible hours- Janssen Biotech, Inc., a member of the Johnson & Johnson Family of Companies is recruiting a Manager,AdvancedCapabilitieslocated in Horsham, PA.At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives...Temporary work
- ...Descriptionooking for a candidate that has planning experience and can show that they have experience with the executive of the entire process of drug development/ clinical trials. Plainsware or any project planning software experience is necessary clinical project manager...Work experience placement
$166.5k - $203.5k
...to FDA, EU Good Pharmacovigilance Practices , and pharmaceutical industry compliance practices, which includes solid knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to global Regulatory Authorities, in particular...Minimum wageFull timeWork at officeLocal areaFlexible hours$117k - $184.2k
...enzymology. The successful candidate will leverage deep knowledge of drug metabolism and biotransformation mechanisms to design and... ...of how enzyme-mediated metabolic processes impact drug efficacy, safety, and developability, while driving innovation and maintaining the...For contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$255.8k - $402.7k
...enterprise leadership and effective collaboration across Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Drug Safety and Pharmacovigilance, Translational Medicine, Medical Affairs, and other key partner functions. The Executive Director...For contractorsImmediate startRelocationVisa sponsorshipFlexible hoursShift work- A leading pharmaceutical company is seeking a Postdoctoral Data Scientist specializing in Oncology to work on cutting-edge cancer research. The role involves performing complex computational analyses, integrating various datasets, and collaborating with scientists to drive...
Johnson & Johnson Innovative Medicine
Spring House, PA15 hours ago - ...Pharmacovigilance Safety Specialist Education: Bachelor's degree or Master's degree or Advance level degree in a life science/healthcare/pharmaceutical related field. Required: Candidate is required to have at least 2 years of pharmacovigilance safety experience...For contractorsFlexible hours2 days per week
AA2IT
North Wales, PA4 days ago $137k - $235.75k
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise...Full timeImmediate startWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Drug Safety. Be the first to apply!
Related searches
- drug safety associate Horsham, PA
- pharmacovigilance manager Horsham, PA
- drug safety physician Horsham, PA
- pharmacovigilance Horsham, PA
- drug safety Horsham, PA
- drug safety scientist Horsham, PA
- drug safety specialist Horsham, PA
- remote drug safety
- pharmacovigilance physician
- associate director pharmacovigilance