Scientific Director (SERM & Clinical Safety & Pharmacovigilance)

About the role

Alphanumeric is seeking a SERM Scientific Director to support a global Safety Evaluation and Risk Management organization. The role provides scientific leadership in evaluating product safety, managing benefit-risk and overseeing pharmacovigilance activities across clinical development and post-marketing programs. It is a full-time, 1-year contract position with potential extension, remote and based in India, with availability during U.S. and/or U.K. business hours.

Key responsibilities

• 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 actions
• Collaborate with internal stakeholders on scientifically sound and compliant safety strategies

Required profile

• 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 RFIs and strong protocol support and regulatory experience
• Proficiency in English is mandatory
• Ability to work independently and escalate issues when needed
• Experience in global cross-functional teams; oncology experience highly desirable but not required

Preferred qualifications

• Experience interacting with FDA, EMA, PMDA and other global regulatory agencies
• Experience supporting global development programs