Clinical - Safety Data Management Associate (Hybrid Position)

Title: Clinical - Safety Data Management Associate

Location: Tampa, FL

Duration: 12 Months+

Job Description:             

Role is 50% onsite

Actual title is Pharmacovigilance Associate I

Per the manager - I would say minimum 2 years experience with any medical electronic content management systems/clinical databases and/or medical writing/ability to summarize medical concepts.

Top 3 skills needed are:

1 - The candidate should possess an understanding of adverse event data and how it relates to pharmacovigilance.

2 - The position requires strong analytical and technical skills with an ability to work in a team environment.

3 - Focus on a strong customer service with pharmacovigilance colleagues by providing timely responses to client requests for information related to safety queries.

Ideal candidate will have an RN, Bachelor’s or Master’s degree in medical science field and be based in the Tampa Bay area. PharmD may be considered. MD is overqualified.

The PV Associate I will support PV operational activities, such as tracking and following up on actions and responses of experts and other stakeholders, as well as ensuring that timelines, resources and information are coordinated and documented accurately and in a timely manner.

SMT Support

• Supports Medical Safety Assessment Physicians (MSAP) in leading and coordinating individual cross-functional SMTs and assigned sub-teams, such as Safety Data Review (SDR) Teams.

• Creates meeting agendas for SMT and assigned sub-teams, and documents of decisions, conclusions, timelines, milestones and action items in team minutes.

• Identifies post-meeting actions, and ensures responsibilities and timelines are assigned and met.

• Assesses and appropriately elevates issues impacting key SMT activities, milestones, documents to the appropriate WWPS colleagues.

• Plans and organizes requirements and/or resources based on Book of Work (BoW) and other upcoming tasks and activities for assigned product portfolio with oversight.

• Applies medical, life science and general scientific knowledge and expertise to create and manage plans for designated projects with oversight.

Signal Detection Support

• Schedules Safety Data Review meetings and attends as able.

• Generate and file signal detection reports and collaborate with Safety Analytics & Reporting (SAR), as needed.

• Signal log entry and signal log report outputs.

• Execute literature searches, deliver output, and retrieve full-text articles, as applicable, applying critical thinking and independent research skills to ensure the information is appropriate and usable.

• Execute Pharmacovigilance Agreement (PVA) searches.

Administrative Support

• Manage access, permissions and content related to SMT SharePoint Online and OneSafe SMT (Veeva Vault SafetyDocs).

• Manage study information received in PV mailbox.

• Maintain SMT membership lists, mail groups, and file shares.

• Manage MSAPSMT mailbox/meeting calendar for assigned product portfolio.

Other Activities

• Work collaboratively with Clinical Safety Program Leads to successfully execute CSP-related activities for protocols, including tracking, reporting, querying, follow up in EDC system, etc. (TAO/RAVE).

• Participate in process improvement projects and implementation.

• Support preparation for regulatory inspections.

• Close safety-related health authority queries in Verity.

• Provide backup coverage to PV Associate II role, as needed.

Key Competency Requirements

• Working understanding of medical concepts.

• Familiarity with safety activities in drug development.

• Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.

• Ability to work well in cross-functional teams.

• Good collaborative and communication skills with scientific subject matter.

• Attention to detail with scientific, analytical and conceptual skills and the ability to reach reasoned conclusions.

• Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, post marketing reports, scientific literature and regulatory documents).

• Possess good (working skills in MS Word, Excel, PowerPoint, SharePoint Online and Outlook.