Medical Director – Clinical Safety & Pharmacovigilance

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

📋 Description

• Oversee safety evaluations and benefit-risk analyses for designated products

• Assist with pharmacovigilance and risk management efforts throughout clinical development and marketed products

• Play a role in regulatory submissions and engage with health authorities

• Draft and assess scientifically robust responses to Health Authority Requests for Information (RFIs)

• Examine and interpret clinical and safety data to aid regulatory and business decision-making

• Engage in cross-functional safety governance and product safety discussions

• Offer protocol and regulatory guidance throughout the development lifecycle

• Elevate significant safety issues and emerging risks when necessary

• Deliver medical leadership for safety evaluation, benefit-risk assessment, and risk management of products in both clinical development and post-marketing environments

⛳️ Requirements

• MD or an equivalent medical qualification

• Extensive experience in clinical development, drug safety, pharmacovigilance, or comparable pharmaceutical roles

• Proficient in responding to Health Authority Requests for Information (RFIs)

• Strong grasp of benefit-risk assessment and safety evaluation

• Experience in supporting regulatory submissions and interactions with regulatory authorities

• Exceptional scientific writing and communication capabilities

• Proficiency in English is a must

• Capability to work autonomously in a fast-paced, highly matrixed setting

• Oncology experience is preferable but not mandatory

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

• Experience in supporting global development initiatives

🏝️ Benefits

• 1-Year Contract with the possibility of extension

• Remote work option

• Availability to work within U.S. and/or U.K. business time zones