Pharmacovigilance Associate I at HAYS

Posted in Other 14 days ago.

Location: Tampa, Florida





Job Description:

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Pharmacovigilance Associate I in Tampa, FL .

Role Description

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.
• 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.
• 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.
• 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.
• 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.

Skills & 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.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1145128


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