Drug Safety Manager

Drug Safety / Pharmacovigilance Manager

The Drug Safety / Pharmacovigilance Manager provides operational and strategic safety support for investigational products across both early- and late-phase clinical development programs. Working closely with internal physicians, cross-functional stakeholders, and external service providers, this position oversees clinical safety activities, supports regulatory compliance, and helps maintain high standards for pharmacovigilance quality and safety monitoring.

Primary Responsibilities

Clinical Safety Leadership

• Act as the primary safety representative for assigned Phase I–III clinical studies in collaboration with Clinical Development, Clinical Operations, and external pharmacovigilance vendors.
• Contribute safety expertise to study protocols, informed consent documents, Investigator’s Brochure safety content, safety management documentation, and monitoring strategies.
• Review and support safety-related content for clinical and regulatory documents, including protocol revisions, clinical study reports, DSURs, and associated narratives to ensure consistency and accuracy prior to approval.

Vendor Oversight & Case Processing

• Monitor CRO and vendor activities related to adverse event case handling, coding practices (MedDRA and WHO Drug), and expedited or aggregate reporting requirements in accordance with applicable regulations and study procedures.
• Evaluate case narratives, line listings, coding quality, and periodic safety outputs to identify inconsistencies, trends, or areas requiring follow-up actions.
• Participate in routine governance and operational meetings with external partners; document performance metrics, risks, and remediation activities through completion.

Safety Monitoring & Signal Evaluation

• Prepare and analyze safety data summaries, including listings, tables, and trend analyses, to support ongoing signal detection and internal safety review discussions.
• Collaborate with medical safety leadership and study physicians in evaluating emerging safety concerns and potential risks.
• Assist with development of risk assessments, mitigation strategies, and safety content for aggregate safety reports and periodic submissions.

Cross-Functional Partnership

• Work alongside medical monitors and clinical physicians on assessment of case seriousness, causality, and medical significance.
• Coordinate with Clinical Operations teams regarding SAE reporting processes, reconciliation activities, and investigator/site training support.
• Provide pharmacovigilance guidance during study startup activities, including vendor planning and safety reporting language.

Compliance & Inspection Readiness

• Support creation and maintenance of pharmacovigilance SOPs, process documentation, templates, and operational guidance materials.
• Contribute to inspection and audit preparedness activities related to drug safety and pharmacovigilance operations.
• Ensure timely and accurate maintenance of safety documentation within TMF and other regulated filing systems.

Qualifications:

Education & Background

• Bachelor’s degree in Nursing, Pharmacy, Life Sciences, Public Health, Biomedical Sciences, or a related scientific discipline required.
• Advanced clinical credentials such as RN, PharmD, PA, or equivalent are preferred.
• Typically requires 5–8 years of pharmacovigilance or drug safety experience within biotechnology, pharmaceutical, or CRO settings, including clinical trial safety oversight experience.

Skills & Expertise

• Strong working knowledge of global pharmacovigilance regulations, ICH-GCP standards, and expedited safety reporting requirements.
• Experience overseeing CRO safety operations, reviewing adverse event processing activities, coding outputs, and related safety documentation.
• Ability to interpret clinical and safety data, identify meaningful trends, and communicate findings effectively.
• Strong organizational, communication, and interpersonal skills with demonstrated success in collaborative, matrixed environments.
• Proficient with Microsoft Office applications and comfortable using electronic safety systems, dashboards, and collaboration platforms.
• Capable of thriving in a fast-moving, team-oriented environment with competing priorities.