Sr. Scientist, Drug Safety

Job Description

The Senior Scientist, Clinical Safety Scientist (CSS) supports safety reporting for clinical trials across multiple therapeutic areas and investigational product development programs, from early- through late-stage development. This includes in-house trials and may include support for outsourced trials from integrations. The CSS collaborates with cross-functional colleagues in clinical development, clinical operations, case processing, and medical safety review.     

Key Responsibilities:

• Intake, review and management of individual reportable safety events from clinical trial investigator sites.

• Ensure that all information required for a clinically complete and accurate case is present.

• Develop clinically focused safety queries for trial investigator sites to support accurate and complete case reports.

• Prioritize daily work to ensure all events are submitted for entry into the safety database within the established timeframes.

• Complete protocol specific activities as required.

• Maintain Protocol Specific Training (PST) requirements for assigned trials, including new amendments, to ensure protocol knowledge and understanding of their impact on safety reporting. 

• Actively participate and ensure effective communication with other team members supporting their protocols.

• Appropriately escalate protocol or individual event issues with other stakeholders including CRAs/CRMs/CS/CD

• May lead one or more protocols (as a protocol lead)

• Triage safety queries from the clinical team and medical safety review team (ICMR-MSR) as applicable.

• As a protocol lead participate as a core member of the Medical Monitoring Team

• As a protocol lead participate and collaborate with the Clinical Trial Team

• As a protocol lead reconcile critical data points between clinical and safety database as required.

• Collaborate closely with cross functional colleagues.

• Collaborate with external colleagues and business partners. 

• May serve as an expert resource for less experienced colleagues.

• May provide training /oversight for new employees.

• May participate in cross-functional or internal initiatives and/or process improvement projects.

• May provide support to outsourced trials.

• May serve as a Business Support team Leader.

Education Requirement:

• Bachelor's degree in Medicine

• Advanced English proficiency (C1 level). Proof of proficiency may be required.

Work Experience:

• Minimum of 2 years of relevant professional experience in clinical practice and/or the pharmaceutical industry, including drug safety, clinical trials, drug development, with at least 1 year of clinical experience in a patient care setting.

Qualifications & Skills

• Strong understanding of scientific and medical concepts.

• Basic understanding of drug development.

• Knowledge of GCP and ICH regulations.

• Ability to work as part of a cross-functional team.

• Effective decision making and independent problem-solving skills.

• Time management and organizational skills.

• Strong communication skills with advanced oral and written English skills.

• Advanced computer, database skills.

• Able to work under pressure, strong sense of responsibility and accountability.

*Please submit your CV in English

Required Skills:

Adaptability, Adaptability, Adverse Event Report, Biopharmaceutical Industry, Clinical Development, Clinical Experience, Clinical Medicine, Clinical Physiology, Clinical Sciences, Clinical Trials, Cross-Functional Collaboration, Data Analysis, Data Integrity, Decision Making, Drug Development, Drug Safety Surveillance, Good Clinical Practice (GCP), Medical Writing, Pharmacovigilance, Process Improvement Projects, Process Improvements, Regulatory Compliance, Risk Management, Safety Reporting, Strategic Thinking {+ 1 more}

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resume