Every day, Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. KSR is the first and largest scientific staffing company in the world, and we currently have an exciting Medical Pharmacovigilance Associate position available northwest of Philadelphia, PA.
A Medical Pharmacovigilance Scientist applies their skills, knowledge, and experience to contribute to the overall safety surveillance of marketed and investigational products. The principle responsibilities of this position include identification of safety signals, thorough evaluation and analysis of safety data, and communication of pertinent safety information with recommendations to Sr. Management
The MedPv Scientist performs periodic aggregate reviews of safety data to identify and analyze safety signals. They will plan the approach for the review of complex safety issues with input from supervisor. He/she clearly communicates (written and/or verbal) interpretation of safety signals and recommends action to resolve safety issues. He/she participates in safety review team meetings by preparing and/or contributing to meeting materials such as draft discussion documents and line listings.
Skills required:
. Plan and writes draft responses to ad hoc safety queries. . Plan and writes draft, Periodic Safety Update Reports (PSURs), expert reports, topic reviews and justification documents.
. Contribute to expert reviews and the development of risk management plans, and other documents or assignments as required. . Ensure documents are scientifically accurate, and meet company and regulatory standards
The MedPv Scientist assists the manager in the day-to-day surveillance activities of assigned products, pertinent safety issues and provision of safety reports within the specific therapeutic area. The MedPv Scientist receives input from all other MedPv personnel, GSSE senior management, other organizations and affiliates, external healthcare professionals, and regulatory agencies.
Minimum Requirements BS in Health Sciences (HS) preferred; 5+ years clinical exp or relevant work exp; pharma required, safety preferred. MS in HS; 3+ years clinical exp or relevant work exp; pharma required, safety preferred. Pharm D w/ 1+ years clinical exp; pharma required, safety preferred
Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly Services. We provide clinical research and scientific staffing to pharmaceutical, biotechnology, medical device and contract research organizations across the US. Kelly Services is an Equal Opportunity Employer.
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Minimum Requirements BS in Health Sciences (HS) preferred; 5+ years clinical exp or relevant work exp; pharma required, safety preferred. MS in HS; 3+ years clinical exp or relevant work exp; pharma required, safety preferred. Pharm D w/ 1+ years clinical exp; pharma required, safety preferred