MARS Solutions Group is looking for an experienced Scientist III/ Drug Safety Scientist , for a client located in San Jose, California, USA . Our client is a well-known Healthcare technologies and organization seeking bright, tech-savvy talent.
Client Industry: Healthcare technologies and organization
Location : San Jose, California, USA
Job Type : 100% Remote (Candidates should live in EST only)
Job Title: Scientist III/ Drug Safety Scientist
Experience Level : Bachelors/Master s degree in Science (Pharmacy, Bio Technology or Chemistry), Experience in pharmacovigilance is a must
Nice to Have Skills : Minimum of 3 years of pharmaceutical/biotechnology PV experience, including clinical trial and post-marketing experience
Schedule/Hours: Work shift 1 st M-F 8AM -5PM - Candidates should live in EST only!
Travel Required (% of travel) No but possible team meeting once per year
Is this a temp to perm position possible hire on but not guaranteed
Essential Responsibilities:
The Drug Safety (DS) Scientist works within Drug Safety & Risk Management group. S/he performs pharmacovigilance tasks and prepares submission-ready regulatory documents within agreed time frames and to a high standard of accuracy, in compliance with GE Healthcare 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.
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..
About MARS Solutions Group:
MARS Solutions Group is an IT staffing firm with access to a wide variety of jobs at various clients across the country. We operate with the consultant's best interests in mind and align them with roles that match their skills, aspirations, and interests. MARS values our relationships with consultants. Therefore, we will stay in touch throughout the duration of the contract to ensure the job is going well and that the role meets their career development needs.
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