Drug Safety Associate Job Description

Drug Safety Associate Job Description

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Drug safety associate provides advice to case processing team in data entry of clinical trial SAEs into Argus safety database and to medical coding of adverse events and diseases according to MedDRA terminology.

Drug Safety Associate Duties & Responsibilities

To write an effective drug safety associate job description, begin by listing detailed duties, responsibilities and expectations. We have included drug safety associate job description templates that you can modify and use.

Sample responsibilities for this position include:

Identify out of scope activities in conjunction with the MSS Functional Lead
Determining the category of information received whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines
Reconciliation activities with all data sources providing safety information - Specialty Pharmacies, Business Partners and Internal Stakeholders to ensure compliance
Manage and process adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines
Accurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirements
Perform post surveillance activities such as literature review and media monitoring
Reconcile activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries and MAPs
Responsible for keeping drug safety databases up to date
Support the Drug Safety Team in ensuring high standards are maintained and opportunities for improvement are identified
Act as record management coordinator for the Drug Safety Team

Drug Safety Associate Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Drug Safety Associate

List any licenses or certifications required by the position: NB

Education for Drug Safety Associate

Typically a job would require a certain level of education.

Employers hiring for the drug safety associate job most commonly would prefer for their future employee to have a relevant degree such as University and Associate Degree in Pharmacy, Science, Medicine, Nursing, Life Sciences, Biophysics, Biotechnology, Biochemistry, Microbiology, Health

Skills for Drug Safety Associate

Desired skills for drug safety associate include:

Medical terminology
Client’s procedures and international drug safety regulations
AE safety profile of assigned products and labeling documents
Case processing conventions and guidelines
Medical terminology and coding systems
Regulatory environment governing safety and risk management activities
AE safety profile of assigned drugs and labeling documents
Data capture conventions and guidelines
Document management systems
MS office and Windows would be beneficial

Desired experience for drug safety associate includes:

Bachelor degree in Medicine, Pharmacy, with good Pharmacovigilance background
Excellent presentation and PC skills
Pharmacovigilance certification or courses is an plus
Good team fit
RN or RPh
As a DSA, you will be expected to perform case processing for serious adverse events, serious and non-serious adverse drug reactions and other medically-related project information such as adverse events of special interest and clinical endpoints

Drug Safety Associate Examples

1

Drug Safety Associate Job Description

Job Description Example
Our growing company is looking for a drug safety associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for drug safety associate
  • Assist with additional Drug Safety Specialist and/or Medical Operations Leader (MOL) activities as required
  • Perform literature searches
  • Review and process serious adverse events, spontaneously reported adverse drug reactions and/or other medically related information per assigned tasks and study specific procedures, serving as a technical expert with regard to all aspects of safety monitoring
  • Assist the MSS Functional Lead (eg
  • Serve as support to the Medical & Safety Services management in all aspects, including coordinating interdepartmental activities (eg
  • Bachelor's degree, or higher in nursing or pharmacy, healthcare professionals preferably
  • Minimum of 5 years of relevant experience, working with a safety database (ARISg preferred)
  • Excellent oral, written and interpersonal communication skills, with writing expertise in the scientific or medical field highly preferred
  • Demonstrable strong organizational and time management skills with the ability to triage and manage multiple responsibilities with a high degree of self-motivation and accountability
  • Experience in cardiovascular therapeutic area preferred
Qualifications for drug safety associate
  • Ability to follow guidelines and procedural documents (experience of working with SOPs ) is preferred
  • Knowledge or experience with Excel, PowerPoint, Visio is preferred
  • Pharmacy qualification or other healthcare related degree or equivalent
  • F drug safety experience in a pharmaceutical company
  • Excellent oral and written communication skills, interpersonal skills and cultural awareness
  • Experience with safety databases (data entry, report generation and ad-hoc queries)
2

Drug Safety Associate Job Description

Job Description Example
Our company is looking for a drug safety associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for drug safety associate
  • Processing 25-30 clinical and post marketed cases per day
  • Managing projects related to reconciliation of cases/database
  • Fielding questions and communication with clinical sites
  • Representing PV Operations as needed on cross functional teams
  • Updating SOPs
  • Other duties as require
  • 3-5 years of Drug Safety/PV Operations experience
  • Experience processing clinical and post marketing cases
  • Ideal candidate will have end to end case processing experience (data entry, coding, assessment of seriousness/listedness/expectedness, writing of narrative, and quality review)
  • Ability to read and understand clinical protocols
Qualifications for drug safety associate
  • Ability to effectively present complex information
  • Registered Nurse or Pharmacist (Certification/licensure is required RN, RPh, PharmD)
  • Pharmaceutical industry experience with a focus on pharmaceutical safety related areas
  • Ability to follow guidelines and procedural documents (experience of working with SOPs preferred)
  • Good computer skills (Word, email) and familiarity with safety systems
  • BA (health science related degree preferred) and 2+ years of drug safety experience in the pharmaceutical industry, or equivalent experience (level determined by experience)
3

Drug Safety Associate Job Description

Job Description Example
Our growing company is hiring for a drug safety associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for drug safety associate
  • Able to work onsite 4-5 days per week
  • Ideal candidate will have Oncology experience, but not required
  • Must be comfortable wearing multiple hats
  • RN, PharmD, or MD + some clinical experience
  • 1 year regulatory or pharmacovigilance experience, or other equivalent clinical or pharmaceutical experience
  • Bachelor’s degree or local equivalent in pharmaceutical, nursing or science
  • Good computer skills (Microsoft Word, Excel, Outlook, Access) and safety database familiarity
  • Be able to work independently and as a part of the team
  • Edit, format, and perform QC checks of PV Aggregate Reports, Safety Topic Reports, and Quality Incident Reports intended for submission to regulatory agencies
  • Importing of documents to the document management system and formatting documents to comply with submission-ready standards
Qualifications for drug safety associate
  • Ability to build relationships and influence key stakeholders
  • Liaising with various stakeholders involved in PSUR preparation
  • Performing quality check of PSURs as per client requirements
  • Responsible for archiving the finalized PSURs and supporting documents as per client requirements
  • Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with timelines communicated by the client
  • Liaising with the relevant stakeholders regarding discrepancies, and for obtaining incomplete/missing information (where required), in order to resolve and clarify issues and to facilitate processing of the reports
4

Drug Safety Associate Job Description

Job Description Example
Our company is hiring for a drug safety associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for drug safety associate
  • Support the coordination, collecting, importing, and submission readiness of PV Report appendices
  • Ensure adherence to defined document naming standards across all PV documents to be located in Shire's Electronic Document Management System
  • Support the PV Scientists Teams in the preparation of internal and external audits, including regulatory agency inspections
  • Assist in the technical and scientific support for safety surveillance and signal detection activities for Shire products
  • Assist the PV Scientist in regulatory commitments to ensure the risks described in the product Risk Tracking Documents and IVEA are efficiently and accurately tracked in the most current versioning of MedDRA
  • Support the PVRM TA Heads in the maintainance of physician eRoom meeting materials, presentations, and product information files on Sharepoint
  • Performing signal detection and safety management committee activities, authoring safety evaluations, contributing and reviewing of aggregate safety reports, assisting with ad hoc regulatory responses, facilitating signal management process for assigned products (i.e., signal tracking, data analysis, leading review meetings, presenting, ) in collaboration with the GSO and Pharmacoepidemiology
  • The PVS will support the GSO with other safety related activities associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management and support activities related to risk minimization including dRMP/RMP and REMS
  • The PVS will provide coordination and oversight to outsourced activities (i.e., signal detection reports, clinical overviews)
  • Interface with Third Party Manufacturers, health care professionals, general public, internal customers, Company functional areas and regulatory agencies
Qualifications for drug safety associate
  • Providing support for audits and inspections
  • Should be familiar regulatory &pharmacovigilance guidelines
  • Should be familiar with pharmacovigilance terminology
  • Abel to perform database/literature searches
  • A Bachelor’s degree in a healthcare or scientific discipline
  • Three plus years of experience in safety management and case processing/reporting
5

Drug Safety Associate Job Description

Job Description Example
Our growing company is hiring for a drug safety associate. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for drug safety associate
  • CRFs and labs, including communication with Study Designated Physicians by interfacing with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance and others to assure query resolution
  • Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator
  • Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data
  • May serve as a representative for Safety Management on cross functional projects, but does not assume decision making
  • Responsibilities in the representative role
  • 20% - Review, revision, negotiation and document management for PV agreements
  • 30% - Maintain processes, tools, and systems for PV Agreements
  • 10% - Training of Global Pharmacovigilance personnel on new and existing PVAs, including key messaging pertaining to commitments
  • 40% - Development and management of compliance tracking processes and systems
  • Routine safety surveillance/signal detection
Qualifications for drug safety associate
  • Ability to prioritize tasks in a timely manner
  • Development of PV clauses for third party agreements and contracts
  • At least one year of pharmacovigilance experience gained from within a pharmaceutical, clinical research or regulatory environment together with a degree in pharmacy, other health discipline or life sciences
  • Understanding of GVP principles and TGA PV regulations are essential together with excellent verbal and written communication, high level of attention to detail and exceptional organisational skills
  • Prepare, perform quality checks of, and submit expedited to the Competent Authority in South Korea using Ezdrug (South Korea Online Portal)
  • Prepare and perform quality checks of global pharmacovigilance intelligence requirements under mentorship of a Senior Safety Reporting Specialist or above

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