Clinical Safety Specialist
6 days ago
Job Title: Clinical Safety Specialist
Job Summary:
We are seeking a highly motivated Clinical Safety Specialist to join our team at Lifelancer. As a Clinical Safety Specialist, you will be responsible for implementing and promoting the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
Key Responsibilities:
- Ensure compliance of operations with governing regulatory requirements
- Create, maintain, and assume accountability for a culture of high customer service
- Efficiency in conducting literature searches for authoring various types of reports
- Author/review various safety reports (or part of such reports) for global regulatory submissions
- Perform/review Signal detection activities
- Author/review RMP ad hoc reports, Safety Update reports, BenefitRisk Evaluation, CCDS supporting document, ACOs Addendum reports
- Perform allied activities like: Generation of line listings and summary tabulation, CFIs, CFCs
- Search literature databases for relevant information, recommend label changes, author proposed label text, and prepare supporting/justification document
- Author/review SOPs/WIs/process documents or sections as applicable
- Impart/conduct Trainings for peers and team members
About Lifelancer:
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.
What We Offer:
We offer a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
Equal Opportunity Employer:
Lifelancer is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind.
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