Senior Drug Safety Associate

08540 Job posted on: 4/10/2008 At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us! We currently have an opportunity for a Senior Drug Safety Associate or Drug Safety Associate based out of our Princeton, NJ facility. •Assist with the overall Clinical Safety and/or Pharmacovigilance operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or postmarketing 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. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business. •It is the responsibility of the post holder 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 EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual. Duties and Responsibilities: •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 with 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. • provide independent QC of AE reports for other members of the group. • May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support • Maintain a strong understanding of Covance’s Argus database conventions or client specific database conventions, as appropriate • Participate in signal detection and trend and pattern recognition activities, as appropriate • Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports of Serious Adverse Events, Annual IND reports, Periodic Reports(PRs) and Product Safety Update Reports (PSURs). • Begin to develop knowledge of Drug Safety Services costing activities. • Begin to prepare Adverse Event Reporting Plans (AERPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency. • Monitor project deliverables regarding contract assumptions; identifying out of scope work. • Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as lead contact for projects including global projects ensuring communication and processes are harmonized. • Actively participates in client meetings and liaise with clients where appropriate. • Assist in the review of cumulative safety data for submission to DSMBs, regulatory authorities or clients. • Assist with the set-up of, and the provision of data to, Safety Committees / Drug Safety Monitoring Boards. • Assist in the co-ordination of endpoint committees as needed. • Work with Data Management or client on reconciliation of safety databases, if appropriate. • Monitor workflow for assigned studies/programs to ensure all deadlines are met • Draft/modify and deliver safety presentations: • Serious Adverse Event reporting at investigator meetings. • Client capabilities meetings, as appropriate • “Department Overview” to internal clients • Maintains a comprehensive understanding of Covance Safety’s SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. • Possess knowledge of other LSDS procedural documents, e.g., SOPs, WIs, etc. impacting safety • Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate • Ensure compliant safety reporting in accordance with US and international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team. • Prepare and/or participate in client or regulatory audits. • Participate 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 scientist in all aspects of case-handling, adverse event reporting and other work as needed.. • Build and maintain good drug safety relationships across functional units. • Demonstrate role specific Competencies on consistent basis • Demonstrate company Values on consistent basis • Any other duties as assigned by management. • Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project. Experience: Required: •Good verbal, written and presentation skills. •Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level. •High degree of accuracy with attention to detail. •Functions as a team player. •Will present and share useful business information across departments and functions •Anticipate/identify problems and takes appropriate action to correct. •Knowledge of medical and drug terminology •Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation •Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products •Knowledge of Medical Device Reporting desirable •Knowledge of Periodic Safety Update Report (PSUR) desirable •Ability to work independently with moderate supervision •Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial. Preferred: •Good knowledge and understanding of industry and R&D processes and objectives. •Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products •Has knowledge of Good Clinical Practice (GCP) related to clinical safety documentation •Applies technical experience and will have full knowledge of other related disciplines Education: Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, Chemistry RN plus 7 years BS/BA* plus 3-4 years MS/MA* plus 2 years PharmD plus 1 year For PharmD, a one year residency of fellowship can be considered relevant experience For BS other than nursing or pharmacy, relevant experience must be specifically in safety. 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, Quality Assurance or Drug Safety Preferred At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. Save to job file |