Scientific Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

• Provide scientific direction in evaluating product safety, managing benefit-risk assessments, and overseeing pharmacovigilance in both clinical development and post-marketing initiatives.

• Lead safety assessment and risk management efforts for designated products.

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

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

• Prepare and review responses to requests for information from health authorities (RFIs).

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

• Participate in safety governance and risk management activities across various functions.

• Recognize new safety issues and propose suitable actions.

• Collaborate with internal partners to ensure that safety strategies are scientifically robust and compliant.

• Play a role in strategic safety decision-making for global programs.

⛳️ Requirements

• An 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 area.

• Proven experience in responding to requests for information from health authorities (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 and escalate issues appropriately when necessary.

• Proven ability to collaborate effectively within global cross-functional teams.

• Experience in oncology is highly preferred but not mandatory.

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

• Experience in supporting global development initiatives.

🏝️ Benefits

• Remote work opportunity based in Brazil.

• Possibility of contract extension.

• Work within U.S. and/or U.K. business time zones.