Scientific Director (SERM & Clinical Safety & Pharmacovigilance) - Remote - Based in India

Alphanumeric Systems; India; Remote; INR 6,000,000 - 9,000,000; Full time

Job summary

Alphanumeric Systems is seeking a SERM Scientific Director to lead global safety evaluation, risk management, and pharmacovigilance activities across development and post-marketing programs.

The role requires independent leadership in safety assessments, regulatory support, and strategic decision-making, with collaboration across cross-functional teams in a remote, India-based setting.

Qualifications

• Advanced scientific or healthcare-related degree required.
• Significant experience in drug safety, pharmacovigilance, or clinical development.
• Experience responding to Health Authority RFIs.
• Strong protocol support and regulatory experience.
• Excellent English communication; ability to work independently.

Responsibilities

• Lead safety review and risk management for assigned products.
• Evaluate safety data from trials, post-marketing sources, and literature.
• Support global regulatory submissions and health authority interactions.
• Draft and review responses to Health Authority RFIs.
• Provide protocol, safety, and regulatory support to clinical teams.
• Participate in cross-functional safety governance and risk management.
• Identify emerging safety concerns and recommend actions.
• Collaborate with stakeholders to ensure compliant safety strategies.

Skills

Analytical thinking

Scientific writing

Communication skills

Regulatory affairs

Education

PhD/PharmD/MS/NP/RN or equivalent

Job description

About the role

Alphanumeric is seeking a SERM Scientific Director to support a global Safety Evaluation & Risk Management organization. This role is responsible for providing scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs. The successful candidate will be a strong scientific leader capable of independently managing safety issues, supporting regulatory activities, and contributing to strategic safety decision-making across global programs.

Location

Remote, based in India.

Employment Type

Full-Time | 1-Year Contract | Potential Extension

Working Hours

Candidates must be available to work within U.S. and/or U.K. business time zones.

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 appropriate actions.
• Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies

Required Qualifications

• 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.
• Strong protocol support and regulatory experience.
• Excellent analytical, scientific writing, and communication skills. Proficiency in English is mandatory.
• Ability to work independently and appropriately escalat issues when needed.
• Experience working effectively within global cross-functional teams

Preferred Qualifications

• Oncology experience is highly desirable but not required.
• Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.
• Experience supporting global development programs.