Job Description
Clinical Risk Management Associate (Part-time)
6 months North Wales, PA 194549Am-1PM EST
Important Notes - Part time role(20hrs/week).
- Can be remote/hybrid/onsite(depending upon candidate's need-all options are open)
- Reporting time: Any time between 9a-3pEST is needed.
- Candidate can break his 20hrs/week over a period of 5 days in a week.
- Should be available for meetings.
- Assignment could be extended beyond 6 months.
Qualifications Education :
- 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.
Experience - 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.
- Candidates will not be seeing the patients.
- The candidates would not be required to have an “active” license.
Must Have - Previous experience in CRO's /academia would be good
- Industry experience is preferred.
- Aggregate review of adverse events reports.
- Review of Individual case safety reports (ICSR).
- Review of adverse event narratives.
- Review of social medial post containing adverse events.
- Therapeutic Areas: Oncology, general medicine. But other Therapeutic Areas experience is fine as well.
- Candidate will be responsible for the Safety & Risk Management for Developmental and Marketed Products.
Software - MS office suite, Veeva(SOP's), RXlogix (PV signals platforms)
Responsibilities - Performs 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.
- 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.
Primary Activities - Primary activities include, but are not limited to:
- 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.
Comments/Special Instructions Day To Day - Perform Safety Analysis for Clinical and post Marketing Data.
- Good Writing Skills.
- Candidate may be working with 7 to 8 colleagues on a program or project.
- Very collaborative environment.
- Working close with Physicians and other groups like Clinical & Regulatory in a very busy space.
- Performs primary medical review of serious adverse experience reports and other AE reports of interest to monitor and describes the safety profile of assigned products.
- Taking an active role in the oversight and development of pharmacovigilance and risk management plans with direction/guidance from the CSRM team Assists the CSRM team to prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for Merck products.
- Strategizes with safety team recommending appropriate data to respond to queries and analyze data.
ueries and analyze data.
About Us: Established in 2004, SPECTRA
FORCE ® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRA
FORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:
Benefits: SPECTRA
FORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRA
FORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRA
FORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRA
FORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com .
LA County, CA Applicant Notice: If you are selected for this position with SPECTRA
FORCE , your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
Job Tags
Permanent employment, Part time, Local area, Remote job,