Scientific Director – Clinical Safety & Pharmacovigilance (Remote, India)

About the role

Alphanumeric Systems is looking for a Scientific Director to provide scientific leadership for a global safety evaluation and risk management organization. The role will guide safety assessment, benefit‑risk management, and pharmacovigilance across clinical development and post‑marketing programs, working remotely from India.

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 interact with health authorities.
• 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.

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.
• Proven experience responding to Health Authority RFIs.
• Strong protocol support and regulatory experience.
• Excellent analytical, scientific writing, and communication skills.
• Ability to work independently and appropriately escalate issues.

Required skills

• Proficiency in English (mandatory).
• Strong analytical and scientific writing abilities.
• Experience with health authority RFIs and regulatory submissions.