Senior Scientist Drug Safety, Clinical Trial Safety Reporting Job
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Clinical Safety Scientist (CSS) in Clinical Trial Safety Reporting is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late stage development. Under the direction of the manager, the CSS will be responsible for intake, initial review, query management and creation of case reports for all reportable safety events according to standard operating procedures. In addition, the CSS will collaborate with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review. The CSS may participate in cross functional or internal initiatives and/or process improvement projects.Qualifications
Education Minimum Requirement:
- BA/BS or equivalent Ex US degree in Life Sciences with 8 or more years’ work experience to include a minimum of 3 years relevant pharmaceutical, drug development/health sciences, and/or drug safety experience.
- Advanced degree (M.S.) or equivalent Ex US degree in Life Sciences with 4 or more years’ work experience to include a minimum of 2 years relevant pharmaceutical, drug development/health sciences, and/or drug safety experience.
- Strong understanding of scientific and medical concepts
- Basic understanding of drug development
- Knowledge of GCP and ICH regulations
- Experience working as part of a cross-functional team setting
- Effective problem solving skills
- Must have excellent project management, and time management/organizational skills
- Strong communication skills with advanced oral and written English skills
- Advanced computer/database skills
- Experience in patient care setting
- Experience in drug safety
- Experience in pharmaceutical drug development
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Drug/Dvcs Sfty Survnce (NonMD)
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck