Scientific Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

• Oversee safety evaluations and risk management processes for designated products.

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

• Assist with global regulatory submissions and engagements with health authorities.

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

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

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

• Detect emerging safety issues and propose suitable actions.

• Collaborate with internal teams to develop scientifically robust and compliant safety strategies.

• Deliver scientific leadership in product safety assessments, benefit-risk analysis, and pharmacovigilance throughout clinical development and post-marketing operations.

• Independently handle safety concerns and play a key role in strategic safety decision-making for global programs.

⛳️ Requirements

• Advanced degree in a scientific or healthcare-related field (PhD, PharmD, MS, NP, RN, or equivalent).

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

• Proven track record in responding to Health Authority Requests for Information (RFIs).

• Strong expertise in protocol support and regulatory matters.

• Exceptional analytical, scientific writing, and communication capabilities.

• Proficiency in English is essential.

• Ability to work autonomously and escalate issues appropriately when necessary.

• Experience collaborating effectively within global cross-functional teams.

• Oncology experience is highly preferred but not mandatory.

• Familiarity with interactions involving FDA, EMA, PMDA, and other international regulatory bodies.

• Experience in supporting global development initiatives.

• Willingness to work within U.S. and/or U.K. business hours.

🏝️ Benefits

• 1-Year Contract with potential for extension.

• Remote work option available for candidates based in Brazil.