Drug Safety Scientist

Job Description

Job Description

Title : Safety Scientist

Location : 196 Broadway, Cambridge MA 02139

Duration : 5 Months

Hybrid role – 2-3 days per week with the team onsite

Shift Hours : Monday to Friday – EST time zone but may need to join cross functional team meetings based in Europe (Belgium and the UK)

Job Description :

Provides in-depth medical / scientific expertise in the safety evaluation and risk management of key Client assets or in clinical development and / or the post-marketing setting.

Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks.

Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of Client global assets to ensure Patient Safety globally.

1. Scientific / Medical Knowledge PV Expertise

• Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
• Leads the safety component of global regulatory submissions.
• Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
• Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information / factors and understanding of the wider context.
• Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
• Explores positions and alternatives to reach mutually beneficial agreements and solutions.

2. Cross-functional Matrix team participation

3. Communications (verbal, written) and Influencing (internal PV Governance and External LTs)

Required and Must Haves :

Company Description

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

Company Description

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.