Kaztronix
http://kaztronix.wpengine.com/wp-content/uploads/2018/11/logo2x-b.png
http://www.kaztronix.com
http://www.kaztronix.com
true
A late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
The Senior Drug Safety Case Manager will independently support the Drug Safety Department. The candidate will work in a role of leadership in development, implementation, and maintenance of a quality system for all Drug Safety activities, encompassing processes, procedures, compliance, and metrics.
Responsibilities
Qualifications
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Senior Drug Safety Case Manager
Job Description
A late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
The Senior Drug Safety Case Manager will independently support the Drug Safety Department. The candidate will work in a role of leadership in development, implementation, and maintenance of a quality system for all Drug Safety activities, encompassing processes, procedures, compliance, and metrics.
Responsibilities
- Assist in overseeing the CRO processing SAE reports on products in accordance with all applicable regulations, guidelines, and SOPs with little or no supervision. This includes detailed review of source documentation, assessing cases for reportability, generation of analysis of similar events, quality check, and overseeing preparation of applicable aggregate safety reports.
- Evaluate project or case workflow and offer solutions for process improvement
- Maintain regulatory and department compliance by ensuring timely completion of reports and assisting in submissions of reportable cases to regulatory agencies (if needed), study investigators, and licensing partners
- Represent the Drug Safety Department in cross-functional team meetings, as needed
- Support coding review of medical history, adverse events, and concomitant medications
- Conduct periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies.
- Draft and update departmental SOPs and other work practices as assigned and maintain consistency with regulatory guidelines and good pharmacovigilance practices
- Participate in training internal and external audiences on drug safety-related topics, as assigned.
- Guide departmental policies and procedures by maintaining a high level of understanding of federal and international regulations
- Draw upon the knowledge of Drug Safety regulations & practices, disease-specific clinical knowledge and understanding of corporate objectives to solve complex problems in creative and effective ways as well as to anticipate routine problems and mitigate them without supervisory intervention
Qualifications
- BS degree in a life science discipline (e.G., pharmacy, or nursing) with 5+ years of relevant experience
- Broad knowledge of domestic and international drug safety regulations, industry practices and standards
- Must have a strong attention to detail, teamwork and initiative
- Must have excellent written and oral communication skills, resourcefulness and personal organization skills
- Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.
- PC literacy required;MSOffice skills (Outlook, Word, Excel, PowerPoint)
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Meet Your Recruiter
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About South San Francisco, CA
Ready to take the next step in your career journey? Explore our job opportunities in the vibrant area surrounding South San Francisco, California! Known for its proximity to the iconic Golden Gate Bridge and the bustling tech hub of Silicon Valley, this region offers unrivaled growth potential and a dynamic work environment. With a unique blend of culture, including the renowned SFMOMA art museum, the lively Castro District, and delectable cuisine like the famous sourdough bread at Boudin Bakery, South San Francisco is the perfect place to thrive professionally while enjoying the beauty of nearby parks like Golden Gate Park and the breathtaking views of the Pacific Ocean. Join us in discovering the endless possibilities for your career in this enchanting region!