Job Details

ID #52697871
Estado Pennsylvania
Ciudad Northwales
Full-time
Salario USD TBD TBD
Fuente ManpowerGroup
Showed 2024-10-14
Fecha 2024-10-15
Fecha tope 2024-12-13
Categoría Etcétera
Crear un currículum vítae
Aplica ya

Clinical Risk Management Associate - I

Pennsylvania, Northwales, 19454 Northwales USA
Aplica ya

Our client, one of the largest pharmaceutical companies in USA is looking for a Clinical Risk Management Associate which is completely remote. Would appreciate candidates from East coast.Job title: Clinical Risk Management Associate - I (Assistant)Location: 100% remoteQualifications: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.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 .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.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 ActivitiesPrimary 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.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 client’s products. Strategizes with safety team recommending appropriate data to respond to queries and analyze data.If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson WellsManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.

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