Associate Director, Safety Scientist

Beacon Hill; Cambridge (MA); On-site; USD 130,000 - 180,000; Full time

Job summary

A leading company in biotechnology research is seeking an Associate Director, Safety Scientist. This role involves supporting risk management activities, signal detection, and safety data analysis, requiring 3 to 5 years of experience in Drug Safety. The successful candidate will contribute to cross-functional safety governance and participate in medical safety oversight of clinical trials.

Qualifications

• 3 to 5 years of experience in Drug Safety / Pharmacovigilance.
• Familiarity with GVP, GCP, and ICH guidelines.
• Experience in signal management and governance teams.

Responsibilities

• Support risk management activities and safety data integration.
• Participate in investigations of drug-related adverse events.
• Contribute to safety evaluation and risk management reports.

Skills

Risk management

Safety reporting

Data analysis

Signal detection

Tools

MedDRA

Safety Databases (Argus)

Job description

Beacon Hill Life Sciences is currently seeking an Associate Director, Safety Scientist.

Responsibilities:

• Support risk management activities by requesting, gathering, consolidating, performing preliminary analysis, and preparing safety data for integration into risk management plans, product labeling, investigational brochures, and Development/Company Core Safety Information.
• Support routine signal detection, signal analysis, and maintenance of signal management tracker by requesting, gathering, consolidating, performing preliminary analysis, preparing safety data, and creating presentations for safety governance meetings.
• Participate and contribute to discussions in cross-functional safety governance forums by preparing presentations and providing input/answers during discussions.
• Participate in investigations of potential drug-related adverse events.
• Provide data analysis of adverse events, safety concerns, and other safety information beyond routine signaling including but not limited to medical information requests, regulatory submissions, safety-related sections of clinical trial documents, health agency queries and product complaints.
• Facilitate timely presentation of pertinent issues to GPV governance for escalation and/or information from weekly case review and clinical trial team meetings.
• Participate in medical safety oversight of clinical trials and contribute to protocol development, safety data evaluation, statistical analysis plans, and clinical study reports.
• Participate in medical review of individual case safety reports and periodic safety reports.
• Contribute (provide content/initial drafts, interpretation, and review) to the safety evaluation and risk management sections of periodic reports for assigned products.
• Contribute to the development of interdepartmental processes and procedures.

Qualifications:

• 3 to 5 years of consistent risk management and safety reporting experience in Drug Safety / Pharmacovigilance.
• Experience in participating in signal management and risk management governance teams.
• Familiarity with Pharmacovigilance and Risk Management regulations and guidelines including Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
• Working knowledge of MedDRA, MedDRA SMQs, and Safety Databases (preferably Argus).
• Familiarity with safety reviews of clinical and post marketing safety data/documents, and working with IBs, study protocols, clinical study reports, informed consent forms and safety submissions.

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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