Drug Safety Specialist Post for Pharma Candidates @ Covance

Covance

Covance, a global contract research organization and drug development services company, has helped bring 49 of the top 50 best-selling drugs to market.

Job Title:    Drug Safety Specialist

Job Description: 

• Assist with the overall Clinical Safety and/or PV&DSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).
• Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.
• Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
• He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual

Essential Job Duties:

• 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 Covance project personnel, if required, within study specified timelines
• Maintain a strong understanding of Covance’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 Covance 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 PV&DSS 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 Covance 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

Qualifications: 

Education/Qualifications

Required:

Non-degree + 4-5 yrs relevant experience (or 2 yrs safety experience)*
Associates Degree + 3-4 yrs relevant experience (or 1-2 yrs safety experience)*
Associate degree RN + 2-3 yrs relevant experience (or 1-2 yrs safety experience)*
BS/BA + 1-2 yrs relevant experience**
MS/MA + 0 yr relevant experience**
PharmD + 0 yrs relevant experience**

Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

*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, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.

Experience:

Required:

• High degree of accuracy with attention to detail.
• Functions as a team player.
• Good Communication.
• 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.
• Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
• Good written and verbal communication skills.
• Ability to work independently with moderate supervision.
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.

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