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

About the role

Alphanumeric is seeking a SERM Associate 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 Brazil.

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

• Contribute to 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 escalate 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.