Pharmacovigilance Associate I

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Pharmacovigilance Associate I

Location: 50% onsite at Lawrenceville

Duration: 6 Months

Pay: $65 - $69.93

Job Description:

Purpose And Scope Of position:

SOE is responsible for ensuring global oversight centrally to fulfill regulatory obligations and deliver high quality regulatory documents to health authorities for safety aggregate reporting and conduct routine compliance monitoring of risk management. This function is also dedicated to collaborate effectively with cross-functional stakeholders with specific focus in WWPS (World Wide Patient Safety) to provide strategic and operational support across therapeutic areas for risk management, signal detection, safety management teams, dedicated support through portfolio strategy and management, to implement effective and distinct processes that are closely monitored for continuous process improvements with optimal technology solutions within safety and oversight and support to Local Market Patient Safety on additional risk minimization measures (aRMMs) implementation worldwide for the company.

Duties And Responsibilities:

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.

Must Have:

Minimum of 2 years professional experience in health science or relevant life sciences/medical fields, or appropriate pharmaceutical industry or academic experience

Demonstrated understanding of global pharmaceutical drug development and drug lifecycles.

Ideal Candidates Would Also Have:

• Demonstrated excellence in scientific technical skills with a comprehensive understanding of pharmacovigilance processes.
• Extensive experience in the analysis and communication of data and information to key stakeholders.
• Project or program management experience and/or qualifications.
• Experience in working with committees and diverse teams.

Other qualifications:

• US military experience will be considered towards industry and professional experience 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.

Education:

BS/RN/MS/PharmD in life sciences or equivalent relevant scientific qualifications or professional training

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.