Scientific Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

• Oversee safety assessments and risk management initiatives for designated products.

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

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

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

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

• Engage in cross-disciplinary safety governance and risk management efforts.

• Detect emerging safety issues and propose suitable measures.

• Partner with internal stakeholders to ensure scientifically valid and compliant safety approaches.

⛳️ Requirements

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

• Extensive experience in clinical development, drug safety, pharmacovigilance, or a similar domain.

• Proficient in responding to Health Authority Requests for Information (RFIs).

• Strong background in protocol support and regulatory affairs.

• Exceptional analytical, scientific writing, and communication capabilities.

• Proficiency in English is essential.

• Capacity to work autonomously while appropriately escalating issues as necessary.

• Proven effectiveness in collaborating within global cross-functional teams.

• Experience in oncology is highly preferred but not mandatory.

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

• Experience in supporting global development initiatives.

🏝️ Benefits

• Potential for contract extension.