PV Specialist
Summary of Position Requirements and Responsibilities
Pharmacovigilance Specialist, Adverse Event Management
Overall Summary
- Reporting to Team Lead, adverse event management who is responsible for the oversight of the Pharmacovigilance Specialist’s responsibility of client relationship.
- Clinicians/healthcare professionals such as MDs, PharmDs, RPHs, RNs or NPs.
- Responsible for participating in adverse event case management in three ways;
- interfacing with clients to review weekly case flows, establish revisions and make judgments about case status
- actually performing cases so that they remain current with the activity
- providing direction to Safety Monitors in terms of the clinical management of the case and its prioritization. As a result, they will set direction for Safety Monitors.
- Support 1-2 clients, depending upon volume and case complexity
- Resolves issues and works with our Medical Review Center of Excellence and Medical Communication Center of Excellence to consistently assess case quality and establish plans and actions for improvements.
Summary of Key Responsibilities & Accountabilities
(Client Engagement, Adverse Event Management Services, Staff, General Business)
- Client contact and overall relationship management
- Client satisfaction
- Development, updating, and maintaining the client conventions/guide for assigned clients.
- Adverse event management services / Case Processing
- 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, as necessary
- AEM services /Aggregate Reporting
- Coordinate with team on Periodic Reports/PSURs 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
- Mentoring, training, and updating of new and existing staff on clients
- Inform appropriate Sentrx staff of delayed, missing or incomplete items; ensure follow-up and completion of all transactions are performed in a timely manner
- 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
- Alert Medical Review staff 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
- General Business
- Assist overall Adverse Event Management 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 facilitate Sentrx management of client expectations.
- Partner with Team Lead in acting as an active participant in new client implementations and client meetings and preparation of meeting agendas and minutes, as required
- Ensure that all internal and client-specific activities are performed in compliance with appropriate Regulatory requirements.
External Constituents
Build and maintain excellent business relationship with client base
Reporting
Indirect
- Support Commercial Development, as needed
- Interact with other members of your AEM unit
- Interacts with other business leaders, including the various Centers of Excellence (Technology Services Group, Medical Review, Medical Communication Center, Finance, Human Resources, Quality Standards)
Summary of Key Requirements
Technical/Functional
Functional Skillscan be provided through experiences at either of bio-pharmaceutical organizations or through service providers such as clinical research organizations
- Clinical background
- Experience in various therapeutic areas with more demanding clinical skills
- 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 PSUR development, medical writing, clinical trial protocol development is of interest
- Clinical Trial and post marketing experience
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Doreen Lechner, PhD EVP Pharmacovigilance Client Services |
