Clinical Risk Management Associate – I – AllSTEM Connections – United States

AllSTEM Connections

United States

2024-10-15

AllSTEM Connections is seeking a Clinical Risk Management Associate – I to work 100% remotely in any mainland US time zone (PST, MST, CST, EST).

This is a six-month contract position. Possible extension/temp-to-hire.

Hourly rate is up to $65.35/hour

M-F, 8AM – 5PM.

SUMMARY:

Candidate will be responsible for the Safety & Risk Management for Developmental and Marketed Products. They will perform primary medical review of serious adverse experience (AE) reports and other AE reports of interest in order to monitor and describe the safety profile of assigned products. Candidates will not be seeing any patients.

RESPONSIBILITIES:

Takes an active role in the oversight and development of pharmacovigilance and risk management plans (RMPs) of assigned products in collaboration with the CSRM physician.
Prepares responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for assigned products and in collaboration with the CSRM physician, strategizes with the Risk Management Safety Team (RMST) recommending appropriate data to respond to queries and analyze data.
Applies clinical, pharmacological, and epidemiologic knowledge and information technology (IT) skills in order to manage the safety surveillance and risk management of assigned products in collaboration with the CSRM physician.
In collaboration with the CSRM physician, accountable for monitoring the overall safety profile of assigned products and for describing the safety profile to ensure external communications regarding the safety of these products are accurate.
Performs safety surveillance review of adverse experience reports for assigned products which includes reviewing individual AE reports, aggregate safety data, published literature, and information from external databases.
Works with CSRM physician and scientist, if applicable to select and analyze the appropriate data from available IT systems in order to investigate safety issues.
Prepares responses to safety inquiries from health care professionals, regulatory agencies, subsidiary staff, and other internal customers.
Demonstrates a working knowledge of pharmacovigilance and risk management; may educate stakeholders outside of CSRM about risk management and the role of CSRM.
Prepares summaries and analyses of safety related data for regulatory documents such as Periodic Safety Update Reports (PSURs), Developmental Safety Update Reports (DSURs) and summaries in support of regulatory filings.

QUALIFICATIONS:

Graduate degree in nursing, health sciences, pharmacology, epidemiology, public health, or other relevant health-related fields.
Advance degree like Pharm-D, PHD, MD’s -preferred.
At least 3 years of experience in clinical, pharmacological, or related field of expertise.
Excellent writing and communication skills are a must.
Experience in data analysis or the interpretation of adverse experience information is a plus.
The candidates would not be required to have an “active” license.
Previous experience in CRO’s /academia would be good
Industry experience is preferred.
Experience with aggregate review of adverse events reports.
Experience with review of Individual case safety reports (ICSR).
Experience with review of adverse event narratives.
Experience with review of social medial posts containing adverse events.
Therapeutic Areas: Oncology, general medicine. But other Therapeutic Areas experience is fine as well.
MS office suite, Veeva(SOP’s), RXlogix (PV signals platforms)

Seniority Level

Associate

Employment Type

Contract

Job Function

Science, Research, and Consulting

Industries

Biotechnology Research, Pharmaceutical Manufacturing, and Research Services