Drug Safety Specialist Job Description

Drug Safety Specialist Job Description

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Drug safety specialist provides medical review of individual case safety reports (clinical and spontaneous), including coding, seriousness, expectedness and Company causality assessment for an assigned therapeutic area.

Drug Safety Specialist Duties & Responsibilities

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

Sample responsibilities for this position include:

Conducts complete clinical reviews of all domestic and foreign adverse event reports for all Acorda investigational and marketed products
Serves as a Safety Liaison contact to other departments and Acorda licensing partners
Actively obtains follow-up through event resolution
Contributes in the conduct of ongoing safety surveillance for marketed and investigational products
Participate in clinical project teams and other interdepartmental teams supporting clinical studies
Acts as a safety representative and facilitator between external reporting sources such as call centers, CROs and investigator sites
Assist in responding to queries from health authorities or outside sources
Management and submission of Individual Case Safety Report from all Spontaneous and Solicited sources
Ensure diligent follow-up attempts to collect all necessary information for case completeness and transmit follow-up reports to the relevant Processing Center in a timely manner
Safety oversight for all local activities potentially triggering collection of safety information

Drug Safety Specialist Qualifications

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

Licensing or Certifications for Drug Safety Specialist

List any licenses or certifications required by the position: EHS, REACH, NB

Education for Drug Safety Specialist

Typically a job would require a certain level of education.

Employers hiring for the drug safety specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Pharmacy, Nursing, Health, Life Science, Life Sciences, Education, Medical, Healthcare, Science, Associates

Skills for Drug Safety Specialist

Desired skills for drug safety specialist include:

Ability to interpret and apply global safety regulations
Drug safety and the drug development process
Patient populations and drug class
Therapeutic area
SOPs
Drug safety databases
MedDRA and WHODRUG coding dictionaries and medical terminology
312.32
Expectedness
FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness

Desired experience for drug safety specialist includes:

May participate as the clinical safety representative on product development subteams
Ensure relevant literature systematic review to collect AEs in local journal and/or for local marketed products not included in the global literature search
Conduct training of non-safety and local safety staff on what their responsibility is in reporting adverse events
Reporting safety information to the Global Drug Safety and local regulatory authority within specified timelines
Maintain oversight of safety risk management and all other pharmacovigilance (PV) activities across all affiliate functions
Ensure constant compliance to the local and global Standard Operating Procedures

Drug Safety Specialist Examples

1

Drug Safety Specialist Job Description

Job Description Example
Our company is looking for a drug safety specialist. 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 specialist
  • Liaise with different functional team members, project management, clinical, data management
  • Provides assistance and advice to Internal and External customers
  • Assumes the leadership and/or contributes to projects relating to departmental processes
  • Ensures that all aspects of the Company’s safety data collection and processing are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements
  • Manages CRO case processing activities in the safety database with respect to compliance with safety agreements
  • Create phone call communication logs in ARISg Triage
  • Support the triage of cases conducted by Senior Specialist as needed Assessment
  • Create key fields updates in ARISg based on QC, as needed
  • Create narratives as needed
  • Review & update auto-narrative as needed
Qualifications for drug safety specialist
  • A degree in medicine, pharmacy, health discipline or life sciences English • 1-3 years pharmaceutical or clinical research experience, pharmacovigilance experience preferred • Knowledge of national and international regulations for pharmacovigilance • Knowledge of pharmacological and medical terminology • Excellent communications, interpersonal and negotiation skills • Computer knowledge • Additional educational requirements as may be mandated by national requirements
  • BA/BS in Life Science or Registered Nurse/Pharmacist
  • University degree in pharmacy, medicine, veterinary medicine or life science
  • First industry experience will be considered an asset
  • Native tongue either German or French and fluent both in written and spoken of the other language, fluent in English in written and spoken is also mandatory
  • Basic knowledge of applicable global, regional, local clinical research regulatory requirements
2

Drug Safety Specialist Job Description

Job Description Example
Our growing company is hiring for a drug safety specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for drug safety specialist
  • Create targeted follow-up letters
  • Review and update generated follow-up letters as appropriate • Authorize (approve) non-serious cases
  • Create major modifications following
  • Liaises with Internal and External customers
  • Provides support and advice to Internal and External customers
  • Assumes leadership and/or contributes to projects relating to departmental processes
  • Provide PV and risk management expertise to internal and external customers
  • Maintain knowledge of product, product environment, and recent literature
  • Lead cross functional Safety Management Teams (SMTs) and GPE internal -Safety Analysis Teams (SATs)
  • Communicate with and represent PV position within project/product teams, with external partners, and key opinion leaders
Qualifications for drug safety specialist
  • Effectively interface with other line functions within Halozyme (e.g., Clinical Development, Regulatory Affairs, Data Management, Finance)
  • Fluent Japanese(reading and writing) business level English(reading and writing)
  • Computer and safety database skills
  • Ability to make effective decisions, manage multiple priorities, exhibit high degree of accuracy, and meet deadlines in a highly dynamic environmen\
  • Ability to be flexible, adapt to change, work independently, part of a team in a matrix environment
  • Bachelor's degree or master's degree in health care/pharmaceutical related field or project management
3

Drug Safety Specialist Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of drug safety specialist. 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 specialist
  • The Drug Safety Specialist will report to (at a minimum) to Associate Director, Case Management
  • Participating and/or providing safety input in business and clinical activities (clinical programs, marketing & launch meetings, sales force convention)
  • Review source documents and ICSR information in order to verify accuracy, completeness and consistency
  • Generate follow-up requests and contact reporters as appropriate to obtain missing case information and/or additional clarifications
  • Learn and understand the existing applications, data models, data flows, integrations, and architecture that make up the Safety Platform
  • Be responsible for leading change management, development, testing strategy, implementation, deployment strategy, and hypercare support for new solutions and for ongoing technical enhancements of existing solutions
  • Explore, evaluate and compare industry and emerging technologies and vendor products which are used in support of safety case intake, processing, signaling, reporting and analytics
  • Collaborate and align on products/technology options with solution architects and focus on innovation and high quality solutions
  • Build effective relationships as part of a large cross-functional team and collaborate with IT, delivery leads, business leads, client service leads, infrastructure, support teams, IT hubs and external vendor partners to implement new & updated solutions
  • Be a primary contributor and ensure the quality of system deliverables including design/configuration specifications, system and user acceptance testing, software installation and the completion of required GxP, System Development Life Cycle (SDLC), and Change Management documentation
Qualifications for drug safety specialist
  • Bachelor’s degree required in a health care discipline
  • Ability to analyze laboratory data and review source documentation of ICSRs
  • Strong knowledge of safety monitoring and pharmacovigilance
  • Ability to write periodic safety reports
  • A minimum of a Bachelor’s degree or the equivalent combination of relevant education or professional experience
  • A minimum 1 year of direct experience within a Drug Safety function in a CRO or Pharmaceutical company
4

Drug Safety Specialist Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of drug safety specialist. 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 specialist
  • Collaborate with team members on the development and implementation of new or revised SOPs
  • Support and contribute to IT strategic plans and roadmaps in support of the Safety Platform and MRL IT portfolio planning process
  • Provide administrative support to PV&DSS personnel
  • Ensure all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Drug Safety Associate or Senior Drug Safety Associate
  • Maintain and distribute a weekly schedule for PV&DSS staff
  • Ensure submission of client-related documents is sent to the client within designated timeframes
  • Assist Drug Safety Associate or Senior Drug Safety Associate in preparation of materials needed for client and/or investigator meetings
  • Review of individual reports, local literature and clinical trials, as required by local regulations for trends and issues arising from reports received
  • Acts as Affiliate Safety Representative (ASR) or as back-up ASR in assigned countries
  • Responsible to manage all queries and requests received in the Drug Safety Contact Line (DSCL) mailbox or via Safety Query Tracking Tool (QTT)
Qualifications for drug safety specialist
  • A degree in medicine or pharmacy OR a degree in pharmacy, health discipline or life sciences
  • Preferably 2-3 years’ experience in the area of pharmacovigilance or related clinical field (or equivalent)
  • A degree within natural science
  • Intermediate/fluent knowledge of English (oral and written) and local/Nordic language
  • Preferably 1 year experience in drug safety / Development or closely related areas of responsibility, but we also encourage newly graduated individuals to apply
  • Awareness of the link between regulations, drug development and drug safety
5

Drug Safety Specialist Job Description

Job Description Example
Our company is growing rapidly and is looking for a drug safety specialist. 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 specialist
  • Assumes responsibility of business owner for the Safety Query Tracking Tool
  • Provide induction training on Safety Query Tracking Tool for new users
  • Assumes responsibility for database searches on the DataMart for ad-hoc searches, DSURs, PBRERs, signal detection, audit- and inspection requests, metrics and any other search request
  • Interacts with internal or external customers to define the criteria for a database search
  • Leads projects or initiatives within Safety Analytics and Reporting, Safety Services or PDS and represents the Data Management Group in projects or initiatives beyond PDS
  • General knowledge of medical scientific literature journal articles (e.g., function, types, use)
  • Provides medical assessment on all cases for seriousness
  • Contribute to, and provide subject matter expertise for PV templates for clinical trial protocols and non-interventional study protocols to ensure compliance with global PV regulations
  • Review and advise on PV content of clinical trial protocols and non-interventional study protocols
  • Participate in interdepartmental and interdivisional meetings in support of individual protocol reviews, input for PV requirements, and related processes
Qualifications for drug safety specialist
  • Awareness of the role of compliance in drug safety
  • Maintains oversight of safety risk management and all other pharmacovigilance (PV) activities and ensures PV compliance and inspection readiness across all affiliate functions
  • Experience in medical writing, strong interpersonal and communications skills, organizational and problem-solving skills required
  • Strong knowledge of FDA regulatory reporting requirements and GMP GCP guidelines required
  • 5+ Years of experience leading large global studies within Clinical Trial Safety required
  • Experience writing Safety Management Plans required

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