Scientific Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

• Oversee safety assessments and risk management initiatives for designated products

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

• Assist with global regulatory filings and interactions with health authorities

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

• Offer protocol, safety, and regulatory guidance to clinical development teams

• Engage in cross-departmental safety governance and risk management efforts

• Recognize emerging safety issues and propose suitable actions

• Work collaboratively 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 similar domain

• Proven experience in addressing Health Authority Requests for Information (RFIs)

• Strong experience in protocol support and regulatory affairs

• Exceptional analytical, scientific writing, and communication abilities

• Proficiency in English is essential

• Capability to work autonomously and escalate issues appropriately when necessary

• Experience collaborating effectively within global cross-functional teams

• Oncology experience is highly preferred but not mandatory

• Familiarity with interactions involving FDA, EMA, PMDA, and other international regulatory bodies

• Experience in supporting global development initiatives

• Willingness to operate within U.S. and/or U.K. business hours

🏝️ Benefits

• Possibility of contract extension