Drug Safety Scientist - Remote

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Title: Drug Safety Scientist - Remote

Mandatory skills:

pharmaceutical, biotechnology PV,

clinical trial, post-marketing,

FDA, EU, ICH guidelines, initiatives, regulations governing pharmacovigilance,

coding, Medical Dictionary for Regulatory Activities, MedDRA,

Microsoft Word, PowerPoint, Excel,

submission-ready regulatory documents, standard operating procedures, clinical trials, post marketing,

Development Safety Update Reports, DSUR, Periodic Benefit-Risk Evaluation Reports, PBRER, US Periodic Adverse Drug Experience Report, PADER,

safety database, create draft reports, data tables, signal evaluation reports

Description:

The Drug Safety (DS) Scientist works within Drug Safety & Risk Management group. Candidate performs pharmacovigilance tasks and prepares submission-ready regulatory documents within agreed time frames and to a high standard of accuracy, in compliance with the client business rules, standard operating procedures and global and local regulatory requirements. The Drug Safety (DS) Scientist will provide scientific support to Drug Safety physicians for safety scientific activities from clinical trials and post-marketing experience.

Primary responsibilities:

Author aggregate safety reports required by health authorities such as, Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER).

Produce high quality, accurate and fit-for-purpose evaluation documents with clear conclusion, in response to internal or regulatory authority safety-related requests.

Run accurate queries and provide standard outputs of the data from the safety database; create draft reports/data tables and to perform searches of the safety database for ad-hoc queries.

Support preparation of RMP and post-marketing safety monitoring activities.

Review publications from worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports.

Conduct routine and ad-hoc signal detection and evaluate safety data and signals as part of ongoing pharmacovigilance activities. This includes the ability to summarize data from multiple sources and authoring signal evaluation reports.

Provide support to the compilation of information for reference safety information (including Company Core Safety Information).

Participate and contribute to Safety Management Team meetings.

Support Drug safety physicians in handling issues related to both clinical and post-marketing safety, as needed.

Perform other duties related to the position as necessary and as defined in SOPs and/or at the request of supervisor.

Minimum of 3 years of pharmaceutical/biotechnology PV experience, including clinical trial and post-marketing experience

Bachelor or Master of Science(required)

Experience in authoring of aggregate safety reports.

Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance. Experience with coding according to the Medical Dictionary for Regulatory Activities (MedDRA).

Ability to function in an environment of rapidly changing priorities and to manage multiple projects simultaneously while maintaining a high level of quality, accuracy and attention to detail.

Excellent oral and written communication skills.

Excellent computer skills, including Microsoft Word, PowerPoint and Excel.

Notes:

100% remote

1st Shift, 8 to 5

VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at for any complaints, comments and suggestions.

Contact Details :

VIVA USA INC.

3601 Algonquin Road, Suite 425

Rolling Meadows, IL 60008