Senior Scientist - Aggregate Reporting

Responsibilities:

The Pharmacovigilance Medical Safety Scientist is responsible for developing, reviewing, and maintaining high-quality safety and pharmacovigilance documents that support the safety surveillance and regulatory compliance of consumer health products.

This role requires the ability to synthesize data from multiple sources, including individual case safety reports (ICSRs), aggregate safety data, clinical studies, epidemiological research, literature reviews, post-marketing surveillance, signal detection activities, and other safety data sources. The successful candidate will transform complex safety information into clear, concise, and scientifically accurate documents that support global pharmacovigilance activities and regulatory submissions.

The individual will work closely with Drug Safety, Medical Affairs, Regulatory Affairs, Clinical Development, Quality, and R&D teams to ensure consistent, evidence-based communication of product safety information.

This is an individual contributor role with no direct reports.

Key responsibilities include, but are not limited to:

Pharmacovigilance and Medical Writing:

1. Prepare, review, and maintain pharmacovigilance and risk management documents for consumer health products. 
2. Synthesize safety information from multiple sources, including:

• Individual Case Safety Reports (ICSRs)
• Aggregate safety data analyses
• Clinical trial safety data
• Post-marketing surveillance data
• Epidemiology studies
• Published literature
• Signal detection and evaluation activities
• Benefit-risk assessments
• Health Authority Assessment Reports

Draft and support the preparation of:

• Periodic Safety Update Reports (PSURs/PBRERs/PADERs)
• Ad Hoc Safety Reports
• Development Safety Update Reports (DSURs) 
• Signal assessment reports
• Aggregate safety reports
• Risk management documentation
• Health authority responses
• Safety narratives
• Safety sections of regulatory submissions
• Safety surveillance reports and presentations
• Analysis and evaluation for the Safety Management Teams (SMT)

Safety Data Analysis and Interpretation

• Collaborate with Safety Scientists, Medical Reviewers and others to evaluate emerging safety information and communicate findings effectively.
• Assist in the interpretation of safety trends, potential signals, and benefit-risk considerations.
• Support literature surveillance activities and summarize relevant safety findings.
• Contribute to the development of safety conclusions and evidence-based recommendations.
• Support the preparation, review, and analysis of risk management activities and reports.

Quality and Compliance

• Ensure all documents comply with global pharmacovigilance regulations, company SOPs, and applicable guidance documents.
• Maintain high standards of scientific accuracy, consistency, grammar, and document quality.
• Perform quality control reviews of safety documents and ensure timely delivery of assigned projects.
• Support inspection and audit readiness activities through accurate documentation practices. 

Education/Experience: 

• Advanced degree required: PharmD, PhD, MD, MPH, MS, or equivalent scientific discipline.
• 8-10 years of experience in pharmacovigilance, drug safety, medical writing, regulatory writing, or related pharmaceutical, consumer health, or medical device industries.
• Experience preparing safety and pharmacovigilance documents preferred.
• Familiarity with global pharmacovigilance regulations and safety reporting requirements.
• Experience working in a matrixed environment with multiple stakeholders. 

Technical Competencies

1. Strong understanding of:

• Clinical research methodologies
• Epidemiology and biostatistics
• Evidence-based medicine
• Regulatory and scientific communication requirements
• Safety and benefit-risk assessment principles

2. Expertise in literature evaluation and scientific data interpretation. 

3. Ability to critically analyze multiple complex scientific information and identify key insights to drive product safety. 

Skills:

• Excellent medical writing, editing, and proofreading skills.
• Exceptional grammar, attention to detail, and document quality standards.
• Strong analytical and critical thinking capabilities.
• Effective project management and organizational skills.
• Strong verbal and written communication skills.
• Ability to work independently while managing multiple priorities and deadlines.