Scientific Director – SERM, Clinical Safety, Pharmacovigilance

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 11%

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Alphanumeric Systems

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1979

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Alphanumeric Systems is a healthcare and life-sciences communications and services firm that provides medical and scientific communications, regulatory writing and submission support, pharmacovigilance, contact center and patient engagement services, KOL engagement, and facilities management and space optimization for pharmaceutical and biotech clients. The company delivers compliance-driven, omnichannel outreach and learning solutions with global reach to support therapy launches, patient access programs, HCP collaboration, and ongoing patient care.

📋 Description

• Lead safety review and risk management activities for assigned products • Evaluate safety data from clinical trials, post-marketing sources, and scientific literature • Support global regulatory submissions and health authority interactions • Draft and review responses to Health Authority Requests for Information (RFIs) • Provide protocol, safety, and regulatory support to clinical development teams • Participate in cross-functional safety governance and risk management activities • Identify emerging safety concerns and recommend appropriate actions • Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies

🎯 Requirements

• Advanced scientific or healthcare-related degree (PhD, PharmD, MS, NP, RN, or equivalent) • Significant experience in clinical development, drug safety, pharmacovigilance, or a related field • Experience responding to Health Authority Requests for Information (RFIs) • Strong protocol support and regulatory experience • Excellent analytical, scientific writing, and communication skills • Proficiency in English is mandatory • Ability to work independently and appropriately escalate issues when needed • Experience working effectively within global cross-functional teams • Oncology experience is highly desirable but not required • Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies • Experience supporting global development programs • Availability to work within U.S. and/or U.K. business time zones

🏖️ Benefits

• Potential contract extension