Drug Safety Job Description
Drug safety
provides technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Drug Safety Duties & Responsibilities
To write an effective drug safety job description, begin by listing detailed duties, responsibilities and expectations. We have included drug safety job description templates that you can modify and use.
Sample responsibilities for this position include:
Possess knowledge of other procedural documents, , SOPs, and how they impact safety
Management of Periodic Aggregated Case Reports
Maintenance of local safety quality management system
Review of coding
Provide support to the Drug Information & Pharmacovigilance Product Support (call) Centre and the related projects, including provision of the Product related information to the callers review and assessment of reported adverse reactions
Supports safety activities for clinical trials, including protocol review, study team representation, document authoring
Retrieval of cases from incoming faxes, files and/or electronic case receipt system, as applicable
Creation of transmittal form and/or electronic documentation of key information, as applicable
Liaison with Case Processing staff, to clarify information
Clarification of unclear or illegible information with LSO, Call Centre, etc
Drug Safety Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Drug Safety
List any licenses or certifications required by the position: NB, EHS, REACH, PMP, ICSR, AALAS, DABT, US, MD
Education for Drug Safety
Typically a job would require a certain level of education.
Employers hiring for the drug safety job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Pharmacy, Nursing, Science, Medicine, Health, Life Sciences, Life Science, Medical, Biotechnology, Biochemistry
Skills for Drug Safety
Desired skills for drug safety include:
Medical terminology
Client’s procedures and international drug safety regulations
Applicable Global Health Authority regulations
Product portfolio and safety profiles for products across therapeutic areas
AE safety profile of assigned products and labeling documents
Case processing conventions and guidelines
Life Sciences Industry
Medical terminology and coding systems
SOPs
Good Clinical Practice related to clinical safety documentation
Desired experience for drug safety includes:
Due to the nature of this position it may be required for the employee to travel
Must be fluent in written and verbal English with good communication skills and basic computer skills
As a DSA, you will be expected to perform case validation 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
Assist the MSS Functional Lead
Coordinate interdepartmental activities
The ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors and sponsors
Drug Safety Examples
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Drug Safety Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of drug safety. 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
- Registry of case to complete basic data entry registry fields
- Assignment of MFR/AER number
- Send case numbers to LSOs/Call Centre, , as applicable
- Management of Individual Case Safety Report (ICSR) from all relevant sources
- Oversight of Risk Management Plan Implementation
- Safety Communication
- Local PV Agreements
- Create draft company comments for serious cases
- Develop event rankings
- Create dechallenge / rechallenge determinations
Qualifications for drug safety
- Normal and routine office duties
- A minimum of 4 years of relevant clinical research I pharmaceutical industry experience, preferably with at least 2 years experience in pharmacovigilance I drug safety
- Medically qualified with an MD or equivalent
- Knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation and risk management, and of the regulatory requirements relating to pharmacovigilance in the US and internationally
- Minimum of 1 year demonstrated knowledge of safety reporting requirements within pharmaceutical environment
- Coordinate and implement department training and identify training needs
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Drug Safety Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of drug safety. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for drug safety
- Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source
- Assist in producing queries of safety data for clients as appropriate
- Assist in the generation and maintenance of the PV&DSS metrics
- Provide input for monthly status reports
- Demonstrate role-specific Core Competencies on a consistent basis
- Oversight of the safety risk management and management of Individual Case Safety Reports (ICRS) from all relevant sources
- Providing guidance to DSA and/or Safety Single Points of Contact in the hub countries
- RMP implementation, contributing to local RMP and ensuring oversight of implementation in the hub countries
- Providing safety communication on all local regulations and educating and training relevant personnel in the affiliate
- Ensure readiness for Audits & Inspections effective CAPA development & management relating to hub operational activities
Qualifications for drug safety
- As a Snr DSA, you will be expected to prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and business partners
- Able to interact collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), with external colleagues
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects)
- As a DSA, you will be expected to prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and business partners
- High School graduate is required
- At least 3 years working experience in Drug Safety or relevant clinical experience
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Drug Safety Job Description
Job Description Example
Our company is looking to fill the role of drug safety. 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
- This role will consist of assessing only serious case reports
- Maintains oversight of all required PV regulatory reporting compliance in a timely manner
- Ensures an Exception Report / CAPA process is in place to manage any non-conformity
- Ensures reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic Reports to the Regulatory Authority and Ethics Committees as required
- Co-ordinates Affiliate review and submission of all periodic safety reports
- Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events and other safety information reportable to PPS from spontaneous and solicited sources and Serious Adverse Events (SAEs) from clinical studies
- Ensures comprehensive data collection and follow-up
- Maintains compliance with local agreements, including reconciliation between partner companies
- Submits other local PV Agreements to PPS for review prior to finalization, in the event these agreements contain variations from the PV Agreement Language templates
- Ensures training of Affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis
Qualifications for drug safety
- RN or Pharmacist/PharmD with minimum of 3 yrs
- Able to interact collaboratively and effectively in a team environment (including Biostatistics, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), with external colleagues
- Healthcare professionals (RN, PharmD)
- MUST be able to produce a high volume of high quality cases within a busy Drug Safety work environment
- One year of pharmacovigilance experience
- Awareness of regulatory requirements related to pharmacovigilance
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Drug Safety Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of drug safety. 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
- Receives clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed
- 50% Document authoring facilitation
- 50% Global Safety Database administrative support
- Performs quality control of key data fields, and makes updates in the safety database per process conventions
- Creates clear, medically concise case narrative procured from relevant information in form of various source documents
- Drafts pharmacovigilance company comment
- Determines follow-up actions and generates letters/queries as appropriate
- Execute phone and/or email communication with customers and interdepartmental groups as necessary
- Support the triage of cases conducted by the Senior Drug Safety Specialist as needed
- Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines and mandates
Qualifications for drug safety
- Awareness of the use of databases and other software applications
- Must be able to navigate pubmed
- Coursework in research methodologies is helpful
- Some college mandatory, Bachelor’s Degree preferred
- ARISg or ARGUS experience
- High School graduate with previous office experience desired
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Drug Safety Job Description
Job Description Example
Our company is hiring for a drug safety. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for drug safety
- Provide support and prepares for regulatory inspection
- Initial triage of incoming AE case reports
- Assessment of AE reports
- Ensuring that individual Adverse Event Case Reports are evaluated against regulatory reporting requirements, ICH-GCP guidelines and Company SOP and procedure
- Perform submission of ICSRs to Regulatory Authorities and to third Partners within GDSRM International
- Addressing instances of technical failure of submission
- Mentoring and training of new hired safety personnel
- The SS is responsible for collecting all safety data relevant to the issue to be evaluated
- SS is to organize all available data into subgroups by decreasing levels of rigor
- Once all relevant safety data have been assembled as indicated above, the SS will assemble an initial draft and begin a preliminary analysis to look for patterns or trends consistent with the hypothesis(es) developed with the GSL
Qualifications for drug safety
- Ability to sort, index and transmit fax/electronic documents
- Good team player with the ability to work independently with accountability for delivery of results
- Ability to follow procedural guidelines, working practices
- Quality orientation with attention to detail and accuracy
- Flexibility and adaptability with a positive attitude
- PharmD, RPh, PhD, or RN with requisite experience