Senior Manager PSS

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt; font-family: verdana, geneva;">Labcorp are recruiting for a Manager/Senior Manager PSS to join the team.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: verdana, geneva;">Role responsibilities:</span></p><ul><li style="color: #000000;"><span style="font-size: 12pt; font-family: verdana, geneva;">Line manage PSS staff including performance reviews, human resource issues, and assist Senior PSS Management in assigning resources to projects.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Manage the overall PSS 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) for specified projects. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">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.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.</span></li><li style="color: #000000;"><span style="font-size: 12pt; font-family: verdana, geneva;">Responsible for the line-management of individuals within a team as well as a project team.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Manage direct reports to ensure staff training records are up to date. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Responsible for managing performance reviews and issues of direct reports.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">May manage individuals across multiple teams and will take on responsibility for cross department projects.</span></li></ul><h2>Education/Qualifications:</h2><h2 style="margin: 0cm 0cm 0pt;"><span>Minimum Required:</span></h2><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;">Level of education required (or experience level which may be substituted for level of education).</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;">Professional designations/certifications/licenses required</span></p><ul><li style="color: #000000;"><span style="font-size: 11pt;">Non-degree + 10 yrs safety experience*</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt;">Associate degree + 8-9 yrs safety experience*</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt;">Associate degree RN + 7-8 yrs safety experience*</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt;">BS/BA + 6-7 yrs safety experience*</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt;">MS/MA + 5-6 yrs relevant experience** (4-5 yrs safety experience)</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt;">PharmD + 3-4 yrs relevant experience** (2-3 yrs safety experience)</span></li></ul><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;">For PharmD, a one year residency of fellowship can be considered relevant experience.</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;">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: 0cm 0cm 0pt;"><span style="font-size: 11pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;">*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: 0cm 0cm 0pt;"><span style="font-size: 11pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;">**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: 0cm 0cm 0pt;"> </p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 11pt;">EudraVigilance Certification preferred</span></p><h2>Experience:</h2><h2 style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Required:</span></h2><ul><li style="color: #000000;"><span style="font-size: 12pt; font-family: verdana, geneva;">Candidates should ideally have at least 4 years line management and/or project management experience and industry experience of which 6 years is relevant to pharmacovigilance/drug safety knowledge.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Good verbal, written and presentation skills.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Work collaboratively with PSS Management’s team</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Strong Leadership capabilities</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Excellent Communication</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Overall departmental resource </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Client service focus</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Ability to multitask and prioritize </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">High degree of accuracy with attention to detail.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Ensure client and global regulatory compliance </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Will present and share useful business information across departments and functions</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Anticipate/identify problems and takes appropriate action to correct.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Knowledge of medical and drug terminology</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Knowledge of Medical Device Reporting desirable</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Knowledge of aggregate reporting </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Financially intuitive</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Proficient knowledge of ICH guidelines.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.</span></li></ul>