LanceSoft, Inc. · 1 month ago
Safety Scientist
Cambridge, MA
Contract
Hybrid
Senior Level, Lead/Staff
$70/hr - $100/hr
7+ years expLanceSoft, Inc. is seeking a Safety Scientist to provide medical and scientific expertise in safety evaluation and risk management of key Client assets. The role involves leading pharmacovigilance efforts, managing safety issues, and participating in cross-functional teams to ensure patient safety globally.
Information Technology
Hiring Manager
Arun Bharadwaj Rapolu
Responsibilities
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
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 prioritize tasks and consistently delivers on deadlines, with high performance standards for quality
Explores positions and alternatives to reach mutually beneficial agreements and solutions
Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling
Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues
Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency
Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently
Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV)
Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others
Leads presentations on recommendations or safety issues to senior staff members at the Client Senior Governance Committees
Has the skillset to interact with confidence, credibility, and influence at all levels of the Client organization. In addition, is expected to represent Client and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners
Qualification
Required
Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, Drug Safety or a related field
Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
Relevant Degree qualification – PhD PharmD – Medic or MD also to be considered
Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes
Experience working in large matrix organizations
Experience in vaccine safety
Strong people management skills – managed a team with direct reports
7+ years of experience
Preferred
Director level experience would be a bonus
Associate director level experience would be a bonus
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
H1B Sponsorship
LanceSoft, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase