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Clinical Medical Affairs III
Ref No.: 18-09401
Location: Horsham, Pennsylvania
Senior Scientist (Pharmacovigilance Scientist II)
Horsham, PA
1 Year Contract
W2 only, NO corp to corp or 1099


The Sr. Scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). The Sr. Scientist will have in-depth product knowledge and will support Safety Management Team (SMT) deliverables as required.
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 Sr. Scientist will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.

PRINCIPAL RESPONSIBILITIES:
Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate (55-65%)
•Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development
•Initiate/Conduct/Oversee searches of internal and external databases
•Perform and/or lead aggregate safety analysis and case level review
•Author, contribute, and coordinate the preparation of core safety deliverables
•Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met
•Partner with vendor to develop reports/deliverables
Provide SMT support as needed (20-30%)
•Act as ad hoc member for assigned products as appropriate
Training/Meetings/Department initiatives (15%)
•Participate in cross-functional training of relevant stakeholders
•Attend departmental meetings and trainings
•Participate in department and/or cross-functional initiatives
•Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or MSO
•Ability to understand nature of adverse drug reactions and complex associations
•High level of flexibility and ability to (re)prioritize work of oneself and others
•Attention to detail and ability to analyze data in broader context
•Ability to work across multiple functions and therapeutic areas
•Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance
REPORTING:
This position reports into the Pharmacovigilance Evaluation and Reporting Director, TA Lead or designee
WORKSING RELATIONSHIP:
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:
•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 Affairs Associates, Managers and Directors
•Clinical and Medical Affairs individuals and organizations (e.g., our financial client, GMARCC, GCO)
•Safety Data Analytics (SDA)/Client Support Desk Staff
•Local Safety Officers
•Client International Pharmacovigilance (IPV) Regional Heads
•Vendor Management
•Business Partners

EDUCATION & EXPERIENCE:
•Bachelor's Degree in Health or Biomedical Science (6-8 years industry experience or equivalent)
•Advanced Degree Preferred in Health or Biomedical Science (4-6 years industry experience or equivalent)
•Clinical/Medical writing or PV experience preferred
•Strong English verbal and written communication skills
•6-8 Years of experience
OTHER COMMENTS:
•Scientific Skillset: Comprehensive Analytic and Conceptual Skills
•Independence: Moderate independence or Independent; (Contributor/Co-lead/Lead)
•SME-In depth product knowledge of assigned products
•Core SMT member or SMT support when needed
•Working knowledge of applicable global, regional, and local regulatory requirements (eg, ICH guidelines)