Drug Safety Specialist I

**Responsibility**:

- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:

- entry of safety data onto adverse event database(s) and tracking systems
- review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- write patient narratives
- code adverse events accurately using MedDRA
- determine expectedness/listedness against appropriate label
- identifies clinically significant information missing from initial reports and ensures its collection
- ensure case receives appropriate medical review
- prepare follow-up correspondence consulting the medical staff accordingly.
- ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
- reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Labcorp project personnel, if required, within study specified timelines
- Maintain a strong understanding of Labcorp’s safety database conventions or client specific database conventions, as appropriate.
- Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
- Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events
- Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
- Work with Data Management or client on reconciliation of safety databases.
- Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.
- Maintains a comprehensive understanding of Labcorp Safety’s Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.
- Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
- Build and maintain good PSS relationships across functional units.
- Demonstrate role-specific Competencies on a consistent basis.
- Demonstrate company Values on a consistent basis.
- Begin to develop a good knowledge of contract assumptions; identifying out of scope work.
- Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
- Begin participating in Labcorp project teams and client meetings as appropriate.
- Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
- Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
- Assist in the co-ordination of endpoint committees, as required.
- Any other duties as assigned by management.

**Experience/Qualifications**:

- Required:_
- Non-degree + 2 years of Safety experience
- or 4-5 years of relevant experience**:

- Associate Degree + 2 years of Safety experience
- or 3-4 years of relevant experience**:

- BS/BA + 1-2 years of Safety experience
- or 2-3 years of relevant experience**:

- MS/MA + 1-2 years of Safety experience
- or 2 years of relevant experience**:

- PharmD + 1-2 years of Safety experience
- or 2 years of relevant experience**:

- For PharmD, a one year residency of fellowship can be considered as relevant experience.
- Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area
- Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
- **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance
- High degree of accuracy with attention to detail
- Functions as a team player
- Good Communication and presentation skills
- Good written and verbal communication skills  Knowledge of medical and drug terminology desirable
- Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation
- Familiarity with ICH Guidelines
- Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
- Ability to work independently with mínimal supervision
- Good keyboard skills,