Raritan, NJ Contract Duration: 6-24 months Rate: Negotiable Salary: NA, $1.00 Responsibilities: Excellent employment opportunity for a Pharmacovigilance Scientist in the Raritan, NJ area. 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). 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, project management/coordination of strategic safety documents, and oversight of deliverables produced by other team members. 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. Training/Meetings/Audits/Inspections: participate in cross-functional training of relevant stakeholders, and act as product or process Subject Matter Expert (SME) during audits/inspections. Participate or lead 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. Experience: A Bachelor's degree in Health or Biomedical Science (6-8 years industry experience or equivalent). An 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.
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