Associate Scientific Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

• Lead scientific initiatives in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities throughout clinical development and post-marketing programs.

• Manage safety issues independently and play a role in strategic safety decision-making for global programs.

• Assist in safety reviews and risk management efforts for designated products.

• Analyze safety data derived from clinical trials, post-marketing sources, and scientific publications.

• Support global regulatory submissions and engage with health authorities.

• Prepare and assess responses to Health Authority Requests for Information (RFIs).

• Offer protocol, safety, and regulatory assistance to clinical development teams.

• Engage in cross-functional safety governance and risk management initiatives.

• Detect emerging safety issues and propose suitable actions.

• Work collaboratively with internal stakeholders to ensure safety strategies are scientifically sound and compliant.

⛳️ Requirements

• An advanced scientific or healthcare-related degree (PhD, PharmD, MS, NP, RN, or equivalent).

• Substantial experience in clinical development, drug safety, pharmacovigilance, or a related discipline.

• Familiarity with responding to Health Authority RFIs.

• Strong background in protocol support and regulatory affairs.

• Exceptional analytical, scientific writing, and communication abilities.

• Proficiency in English is essential.

• Capability to work independently while appropriately escalating issues when necessary.

• Experience in effectively collaborating within global cross-functional teams.

• Oncology experience is highly preferred but not mandatory.

• Experience interacting with regulatory agencies such as the FDA, EMA, PMDA, and others globally.

• Experience supporting global development initiatives.

🏝️ Benefits

• 1-Year Contract with the possibility of extension.

• Remote work opportunity based in Brazil.

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