Job Description
Overall Summary
• Reporting to EVP Pharmacovigilance Services, who is responsible for the oversight of the Team Lead’s responsibility of client relationship and meeting our financial and client satisfaction targets. Working well, Team Leaders enable our EVP Pharmacovigilance Client Services to focus efforts on strategic growth initiatives, senior level client management and to support new business development efforts. In other words, the EVP Pharmacovigilance Client Services is free of daily operations responsibilities, if Team Leads are properly working
• Clinicians/healthcare professionals such as MDs, PharmDs, RPHs, RNs or NPs
• Responsible for participating in adverse event case management in the following ways;
1. Single point of accountability for the client for contracted services inclusive of Pharmacovigilance and Technology related services
2. Client engagement to assure that the client’s needs are met inclusive of review of weekly case flows, establish quality cases and make judgments about case status in the absence of the Pharmacovigilance Specialist
3. Setting direction for the AEM unit team by providing oversight to the PV Specialist, Safety Monitor and Associate Medical Safety Officers and respective staff to assure they have guidance interms of the collection of a clinical relevant case information, the clinical management of the case and its prioritization
• Support multiple clients, as many as 5, depending upon volume and case complexity
• Leads the creation of required resource team to support the client, setting direction, resolving issues and working with their assigned team to consistently assess case quality and establish plans and actions for improvements
Summary of Key Responsibilities & Accountabilities
(Client Engagement, AEM Services, General Business)
Client Engagement
• Client contact and overall relationship management to assure all clients needs are met inclusive of services and technology, as appropriate
• Client satisfaction and renewal of services on a continuing basis inclusive of amending current service contracts, if necessary
• Development, updating, and maintaining the client conventions/guide for assigned clients, as necessary
• Identifies new opportunities with existing clients inclusive of preparation of new service contracts
• Deliver client performance metric reports on time
• Produces revenues and targeted gross margins related to contract; communicates and maintains future case volumes
• Coordinate and lead client meetings inclusive of preparation of agenda and minutes as well as keeping current on resolution of client requests
AEM services/Case Processing
• Lead a client focused unit of Adverse Event personnel of HCPs; other direct reports may be assigned as needed to advance business outcomes
• Ensures performance objectives. e.g., delivers “submission ready” cases to client specifications while ensuring regulatory compliance
• Case processing “expert” at the client level, as appropriate
• Meet specific project milestones and standards, which include volume, timelines and data quality
• Handle initial and follow-up pharmacovigilance transactions from consumers, health care professionals, attorneys, or investigators, as necessary
• Perform triage of cases prior to case processing, as appropriate
• Responsible for quality levels and revision rates of client; all aspects of client revisions including running report, completing/assigning revisions, compiling data, developing strategies to reduce revisions, mentoring staff on revisions, and communicating revision information to the client
• Responsible for completion/assignment of expedited cases to ensure regulatory and client deadlines are met
• Perform Integrity review for those clients that do not require a formal Medical Review
• Responsible for development, updating and maintaining AEM procedural documents
AEM Services/Aggregate Reporting
• Coordinate with team on preparation of aggregate reports or signal detection/trending and data lock dates
• Assist in running ad hoc reports from the client safety database to support client or regulatory health authority queries
Team Communication & Support
• Development and maintenance of client specific Role Base Curriculum
• Mentoring, training, and updating of new and existing staff on clients
• Ensure staff complete required training on a timely basis
• Inform appropriate Sentrx staff of delayed, missing or incomplete items; ensure follow-up and completion of all transactions are performed in a timely manner, informing appropriate Sentrx staff of delayed, missing or incomplete items
• Communicate to team via team meetings; meet with staff on a routine basis to provide feedback on case volumes and case quality
• Coordinate with Medical Communication Center to assure the appropriate collection of relevant adverse event case information, communication of correct medical information and collection of product complaint issues, if assigned a client that requires Medical Communication support
• Utilize Medical Review/Integrity staff to assist in resolving of issues to assure patient safety, manage client risk, understand and manage salient clinical/medical issues, adjudicate and reconcile conflicting or difficult clinical issues. Minimize Sentrx risk and collaborate with Quality Standards to assure regulatory compliance
• Participate in quality assessment reviews and audits, e.g. prepare appropriate responses to findings identified, fulfill response commitments in a timely manner
General Business
• Actively participate in AEM Staff meetings held by the head of AEM by being prepared with client updates
• Utilize the support of thePharmacovigilance Case Manager and Pharmacovigilance Quality Manager toalign resources and case quality on your respective team
• Assist overall AEM organization in critical tasks on an as needed basis. Tasks include, but are not limited to data entry, follow-up action items, and other various projects
• Interact with Sentrx Executive Leadership team in communicating key issues and milestones, and facilitateSentrx management of client expectations
• Active participant in new clientimplementations and client meetings and preparation of meeting agendas andminutes, as required
• Ensure that all internal and client-specific activities are performed in compliance with appropriate Regulatory requirements and Sentrx Quality Management process
• Participate in Sentrx performance review process
External Constituents
Build and maintain excellent business relationship with client base
Reporting
Direct
Respective resource team to support client
Indirect
• Support Commercial Development, as needed
• Interacts with other business leaders, including the various Centers of Excellence (Technology Services Group, , Finance, HR, Quality Standards and Internal Operations)
Job Requirements
Summary of Key Requirements
Technical/Functional
Functional Skills can be provided through experiences at either of bio-pharmaceutical organizations or through service providers such as CROs
• Clinical background
o Experience in cardiovascular, oncology and other speciality therapeutic areas with more demanding clinical skills
o Able to handle high case volume as well as complex cases
• PV experience, includes safety system experience, case processing, interfaces with global safety teams or other teams formed to assess the continuing safety profile for the compound or product; experience in aggregate report development, medical writing, clinical trial protocol development is of interest
• Clinical Trial and post marketing experience
• Prior project management or team leadership
Travel
As deemed necessary by management
Sentrx Leadership Skills
• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; establishes and maintains effective relationships with customers and gains their trust and respect.
• Managing Vision and Purpose: Creates and communicates a compelling and inspired vision or sense of core purpose; creates mileposts and symbols to rally support behind the vision.
• Dealing with Ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn’t upset when things are up in the air; doesn’t have to finish things before moving on; can comfortably handle risk and uncertainty.
• Hiring and Motivating: Has a nose for talent; hires the best people available from inside or outside; is not afraid of selecting strong people.
• Challenging the Process: Willing to search out challenges and to experiment with new ideas that may drive improvements in business outcomes.
• Enabling Others to Act: Ability and willingness to foster collaboration and to strengthen staff by yielding power, providing choice, redeveloping talent.
About this companySentrx, a part of Telerx
About Sentrx
We are drug safety experts. Our highly experienced teams of healthcare professionals and other pharma industry experts focus in safety technology systems, adverse event management and medical affairs. Sentrx solutions are customized, integrated and scalable to improve efficiency, reduce cost, and improve flexibility. Our experience is unmatched, built over 16 years serving a broad range of bio-pharmaceutical clients, including CROs.
To learn more about Sentrx, visit our new website at www.sentrx.com
About Telerx
Telerx, a subsidiary of Merck & Co, Inc., offers complete management of complex and sensitive interactions in the healthcare marketplace including, access & reimbursement, product recalls and critical events, quality and compliance and patient assistance among others. The company adheres to strict regulatory requirements and standard operating procedures related to the Pharmaceutical industry. Over 90 percent of the company’s clients are FDA-regulated. Telerx has corporate headquarters in Horsham, Pennsylvania with additional contact centers in Allentown and Wilkes-Barre, Pennsylvania, El Paso, Texas and Kings Mountain, North Carolina.
For more information visit Telerx.com
Country: USA, State: New York, City: New York, Company: Telerx.
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