Scientific Director – Clinical Safety, Pharmacovigilance

This is a fully remote position, open to applicants in India.

📋 Description

• Deliver scientific guidance in assessing product safety, managing benefit-risk profiles, and overseeing pharmacovigilance efforts throughout clinical development and post-marketing initiatives.

• Oversee safety evaluations and risk management processes for designated products.

• Analyze safety information from clinical trials, post-marketing data, and scientific publications.

• Assist in global regulatory submissions and engage with health authorities.

• Prepare and review responses to Health Authority Requests for Information (RFIs).

• Offer protocol, safety, and regulatory assistance to clinical development teams.

• Engage in cross-functional safety governance and risk management efforts.

• Recognize emerging safety issues and propose suitable actions.

• Partner with internal stakeholders to develop scientifically robust and compliant safety strategies.

⛳️ Requirements

• Advanced degree in a scientific or healthcare-related field (PhD, PharmD, MS, NP, RN, or equivalent).

• Extensive experience in clinical development, drug safety, pharmacovigilance, or a related area.

• Familiarity with responding to Health Authority Requests for Information (RFIs).

• Strong foundation in protocol support and regulatory affairs.

• Exceptional analytical, scientific writing, and communication abilities.

• Proficiency in English is essential.

• Capability to work independently while knowing when to escalate issues appropriately.

• Experience collaborating effectively within global cross-functional teams.

• Oncology experience is highly desirable, though not mandatory.

• Experience liaising with FDA, EMA, PMDA, and other international regulatory bodies.

• Background in supporting global development programs.

🏝️ Benefits

• 1-Year Contract with potential for extension.

• Remote work flexibility.

• Opportunity to work within U.S. and/or U.K. business hours.