Job Description

At Astrix, we're expanding our team to support a diverse range of clients across various industries. We're seeking talented Drug Safety Physicians to join us! Our partners range from emerging biotech firms to established pharmaceutical companies, all seeking professionals who can bridge scientific insights with clinical application. Opportunities are available both remotely and on-site throughout the country!

Location: Central Region (Remote with Onsite Collaboration as Needed)
Salary Range: $180,000 - $250,000 (based on experience and qualifications)

Key Responsibilities:

• Conduct medical reviews of individual case safety reports (ICSRs) to assess seriousness, expectedness, and causality.
• Contribute to the preparation and review of aggregate safety reports, including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
• Participate in signal detection activities and safety data analysis to identify potential safety concerns.
• Provide medical input into clinical trial protocols, investigator brochures, informed consent forms, and other clinical documents.
• Collaborate with cross-functional teams to integrate safety considerations into product development.
• Support the preparation of safety sections for regulatory submissions and responses to health authority inquiries.
• Stay current with global pharmacovigilance regulations and guidelines to ensure compliance and best practices.

Qualifications:

• Medical degree (MD or equivalent) required; board certification in a relevant specialty is preferred.
• Minimum of 3 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry.
• Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).

Preferred Qualifications:

• Experience in oncology, infectious diseases, or other specialized therapeutic areas.
• Familiarity with signal detection methodologies and tools.
• Experience in authoring and reviewing safety-related regulatory documents.

This is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH

Job Tags

Full time,

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