Manager, Drug Safety Services

08540 Job posted on: 4/17/2008 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!  Currently we are seeking a Mgr, Drug Safety Services to manage the Drug Safety Services team based out of our Princeton, NJ facility. In this role you will: •Manage 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. •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. Duties and Responsibilities: •Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project. •General oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. •General oversight for the management and processing of expeditable adverse event reports. •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 awareness of Covance’s safety database (Argus) conventions and system functionality and other client safety database conventions and functionality. •May prepare, but definitely provide oversight to the timely preparation of 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). •Responsible for the preparation and review of Adverse Event Reporting Plans (AERPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency. •Draft and execute Safety Monitoring plans •Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms. •Consistently responsible for assisting with the set-up of, and the provision of data to, Safety Committees / Drug Safety Monitoring Boards •Contribute to the generation and review of Time and Cost Estimates for Drug Safety Services business. •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 •Review safety costs for allocated projects, identify out-of-scope/unauthorized activities and work with the appropriate LSDS business units to process change orders, expeditiously. •Prepare and participate in audits, either by the client or a regulatory agency. •Assist in developing Operational metrics measuring Safety’s overall performance. •Serious Adverse Event reporting at investigator meetings. •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. •Train new employees overall in pharamcovigilance and regulatory reporting. •Financial authority as it relates to projects. Travel: 5% Experience: •At least 2 years line management and/or project management experience. •Industry experience of which 4 years is relevant to drug safety knowledge. •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. •Work collaboratively with Safety Management’s team •Leadership capabilities •High degree of accuracy with attention to detail. •Ensure client and global regulatory compliance. •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 •Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial. •Financially intuitive •Extensive knowledge of the relevant worldwide regulations and guidelines. •Knowledge of ICH GCP guidelines. •Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance. Education: •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. •To be considered candidate must possess relevant experience specifically in safety/AE processing (minimum of 4 years of safety experience in both pre and post-marketing safety reporting) along with 1-2 years supervisory experience •RN + 7 yrs •BS/BA + 6yrs •MS/MA + 5 yrs •PharmD + 3 yrs 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 |