Pharmacovigilance Scientist II / Drug Safety Aggregate Reports (REMOTE-WORK)
Pioneer Data Systems Inc
Our client, a world-leading Pharmaceutical client in Horsham, PA is currently looking for a Pharmacovigilance Scientist II / Drug Safety Aggregate Reports (REMOTE-WORK) to join their expanding team.
Job Title: Pharmacovigilance Scientist II / Drug Safety Aggregate Reports (REMOTE-WORK)
Duration: 6 months contract, extendable up to 24 Months
Location: Horsham, PA
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Senior Scientist (Pharmacovigilance Scientist ll)
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.
Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
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
Act as ad hoc member for assigned products as appropriate
Participate in cross-functional training of relevant stakeholders
Attend departmental meetings and trainings
Participate in department and/or cross-functional initiatives
Decision-Making And Problem-Solving
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
This position reports into the Pharmacovigilance Evaluation and Reporting Director, TA Lead or designee
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
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)