Job Description

Title – Drug Safety Scientist Tentative start date – asap Tentative end date – 12 month Work shift (days/times) – 1st Shift, 8 to 5 Work Location – 100% remote, candidates preferred to be 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 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.
• 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.

Employee Benefits: At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits: Four options of medical Insurance Dental and Vision Insurance 401k Contributions Critical Illness Insurance Voluntary Permanent Life Insurance Accident Insurance Other Employee Perks About LanceSoft LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch. #J-18808-Ljbffr LanceSoft Inc

Job Tags

Permanent employment, Full time, Temporary work, Immediate start, Worldwide, Shift work, Day shift,

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