Assoc Mgr PSS

<h2>Job Overview:</h2><ul><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">Responsible for the line-management of individuals within team as well as a project team.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Manage direct reports to ensure staff training records are up to date. </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Responsible for managing performance reviews and issues of direct reports.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">May manage individuals across multiple teams and will take on responsibility for cross department projects.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">May lead or assist with the management of PSS concerning project allocation and resourcing.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">General oversight for 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, oversight of the following types of tasks:</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">Entry of safety data onto adverse event tracking systems</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">review of adverse events for completeness, accuracy and appropriateness for expedited reporting</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">write patient narratives</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">code adverse events accurately using MedDRA</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">determine expectedness/listedness against appropriate label</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">identifies clinically significant information missing from initial reports and ensures its collection</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">ensure cases receive appropriate medical review</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">prepare follow-up correspondence consulting with the medical staff accordingly </span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">file maintenance</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">General oversight for the management and processing of expeditable safety reports (ESRs). This includes, but is not limited to, oversight of the following types of tasks:</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">review and update adverse event databases and tracking systems</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">review of adverse events for completeness, accuracy and appropriateness for ESR</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">review of patient narratives</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">review the coding of adverse events </span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">file maintenance</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Maintain awareness of Covance’s safety database conventions and system functionality.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Maintain awareness of other client safety database conventions and functionality.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting. </span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">Provide oversight and management of EudraVigilance activities for assigned projects.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Contribute to the generation and review of Time and Cost Estimates for PSS business.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Prepare and participate in audits, either by the client or a regulatory agency.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Consistently contributes to solving technical and/or operational problems identified by program/project members.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Consistently proposes and executes innovative solutions which influence program/project direction.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Generation of monthly status, staff member performance and other project-specific reports ensuring the quality and accuracy of metrics and data provided.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Effectively draft/modify and deliver safety presentations:</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Client capabilities meetings, as appropriate</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">“Department Overview” to internal clients</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Attend client meetings and liaise with clients where appropriate.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Train new employees overall in pharamcovigilance and regulatory reporting.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Maintain a comprehensive understanding of Covance PSS’ SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Possess knowledge of all other CDS procedural documents that impact Patient Safety Solutions.</span></li><li style="margin-left: 27.0pt;"><span style="font-size: 10pt;">Assist with the generation and review of SOPs, Work Instructions etc.</span></li><li style="margin-left: 27.0pt;"><span style="font-size: 10pt;">Responsible for SOP implementation within assigned team.</span></li><li style="margin-left: 27.0pt;"><span style="font-size: 10pt;">Assist in developing Operational metrics measuring PSS’ overall performance.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Assist with the recruitment of new staff to Patient Safety Solutions.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Build and maintain good PSS relationships across functional units.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Demonstrate role specific Competencies on consistent basis.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Demonstrate company Values on consistent basis.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Financial authority as it relates to personnel and projects.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Any other duties as assigned by management.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Strong relationship-building and interpersonal skills.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Good ability to assess staff performance and propose effective strategies to enhance existing strengths and fill any noted skill or knowledge gaps.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Good ability to propose solutions to effectively address any performance issues.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to provide mentorship and guidance to project support staff.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to grow and develop project support staff through multiple levels within the department career ladder.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to coach project support staff in development of technical skills, efficiency and quality.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to work independently in a staff management capacity, in regular consultation with management.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to perform project review and process analysis, identify potential risks and process improvements – and propose appropriate action.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Functions as a positive, engaging and motivating team player.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to direct, manage and coordinate the day-to-day efforts of multiple levels of staff.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to effectively manage multiple internal and external customers competing concurrently for attention, services and resources.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Good verbal, written and presentation skills.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Work collaboratively with PSS Management’s team</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Leadership capabilities</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Good Communication</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">High degree of accuracy with attention to detail.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Ensure client and global regulatory compliance. </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Will present and share useful business information across departments and functions</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Anticipate/identify problems and takes appropriate action to correct.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Knowledge of medical and drug terminology</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Knowledge of Medical Device Reporting desirable</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Knowledge of aggregate reporting desirable</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Financially intuitive</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Knowledge of ICH guidelines.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 10pt;">Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.</span></li></ul><h2>Experience:</h2><p style="margin: 0px;"><span style="font-size: 10pt;">Level of education required (or experience level which may be substituted for level of education).</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Professional designations/certifications/licenses required:</span></p><p style="margin: 0px;"><span style="font-size: 10pt;"> </span></p><ul><li style="margin-left: 0cm;"><span style="font-size: 10pt;">Non-degree + 6-7 yrs safety experience* including 2 years of team leadership experience***</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">Associate degree + 5-6 yrs safety experience* including 2 years of team leadership experience</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">Associate degree RN + 5-6 yrs safety experience* including 2 years of team leadership experience</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">BS/BA + 4-5 yrs relevant experience* including 1-2 years of team leadership experience</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">MS/MA + 3-4 yrs relevant experience** (2-3 yrs safety experience) including 1-2 years of team leadership experience</span></li><li style="margin-left: 0cm;"><span style="font-size: 10pt;">PhD / PharmD + 2-3 yrs relevant experience** (1-2 yrs safety experience) including 0-2 years of team leadership experience</span></li></ul><p style="margin-bottom: .0001pt;"><span style="font-size: 10pt;"> </span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10pt;">For PharmD, a one year residency of fellowship can be considered relevant experience.</span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 10pt;">*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. </span></p><p style="margin: 0px;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 10pt;">**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.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0px;"><span style="font-size: 10pt;">***Team leadership experience includes experience bearing overall responsibility for work products generated for customers by supporting team members operating in matrix environment, assigning and coordinating work executed by a team of supporting staff, organizing efforts of more than one individual to achieve common team objectives.  </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10pt;">EudraVigilance Certification preferred</span></p>