Pharmacovigilance Safety Scientist

  •  

Horsham, PA

Less than 5 years

Posted 170 days ago

This job is no longer available.

POSITION SUMMARY:

 

The Scientist will be responsible for assigned tasks related to core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (small to medium volume, standard complexity). Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. The Scientist will partner with team members, stakeholders, and a vendor.

 

PRINCIPAL RESPONSIBILITIES:

85% of the time:

?       Ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate

?       Collaborate with PVER team members to perform assigned tasks, Interact with other stakeholders (e.g Safety Surveillance Physician (SSP), Medical Safety Officer (MSO)) on relevant deliverables

?       Initiate/conduct searches of internal and external databases

?       Perform aggregate safety analysis and case level review

?       Author/contribute to the preparation of core safety deliverables

?       Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met as appropriate for assigned tasks

?       Partner with vendor to develop reports/deliverables

15% of the time:

?       Training/Meetings/Department Initiatives

?       Participate in department training

?       Training of task or process-related activities

?       Participate in department initiatives as appropriate

 

DECISION-MAKING AND PROBLEM-SOLVING:

?       Recognize potential issues and or safety issues and escalate to report owner or line manager

?       Ability to understand nature of adverse drug reactions

?       High level of flexibility and ability to (re)prioritize work

?       Data cleaning/QC skills

?       Attention to detail and ability to organize data

?       Ability to work across multiple functions and therapeutic areas

?       Evaluate and incorporate reviewer comments in draft reports and respond accordingly

 

REPORTING RELATIONSHIPS:

This position reports into the Pharmacovigilance Evaluation and Reporting Director, TA Lead or designee

 

WORKING RELATIONSHIPS/INTERFACES:

Global Medical Safety Operations (GMSO) is a functional area within Global Medical Organization (GMO)

Will work in a matrix environment interface with the following functions as needed to complete deliverables:

?       Vendor Management

?       TA Safety Head

?       Medical Safety Officer (MSO)/designee

?       Compound Development Team members

?       Medical Safety Surveillance and Insight Physicians and Staff

?       Management and Scientists, Global Case Management

?       Epidemiology Staff

?       Compliance, Standards and Analytics (CSA) group

?       Regulatory AffairsAssociates, Managers and Directors

?       Clinical and Medical Affairs individuals and organizations (e.g., GMAC, GMARCC, GCO)

?       Safety Data Analytics (SDA)/GMSSupport Desk Staff

?       Local Safety Officers

?       GMSInternational Pharmacovigilance (IPV) Regional Heads

?       GMO Senior Leadership Team

?       Office of the QPPV

?       Regulatory Medical Writing Personnel

?       Vendor Management

?       Business Partners

 

EDUCATION & EXPERIENCE REQUIREMENTS:

?       Bachelor?s Degree in Health or Biomedical Science (3-5years industry experience or equivalent)

?       Advanced DegreePreferred in Health or Biomedical Science (2years industry experience or equivalent)

?       Clinical/Medical writing or PV experiencepreferred

?       Strong English verbal and written communication skills

 

OTHER REQUIREMENTS:

?       Scientific Skillset: Analytic and Conceptual Skills

?       Independence: Minimal independence; (Contributor/Co-lead)

?       Knowledge (Product and Regulations): Safety Management Team (SMT) support when needed

?       Awareness of applicable global, regional, and local regulatory requirements (e.g., ICH guidelines)