Scientific Director – SERM, Clinical Safety, Pharmacovigilance

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

📋 Description

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

• Lead safety assessments and risk management strategies for designated products.

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

• Support global regulatory submissions and engage with health authorities.

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

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

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

• Identify and address emerging safety issues, recommending suitable actions.

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

• Independently oversee safety matters and contribute to strategic safety decision-making on a global scale.

⛳️ 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 similar domain.

• Proven experience in responding to health authority requests for information (RFIs).

• Strong background in protocol support and regulatory affairs.

• Exceptional analytical, scientific writing, and communication abilities.

• Proficiency in English is essential.

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

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

• Oncology experience is highly valued but not mandatory.

• Background in interactions with regulatory agencies such as FDA, EMA, PMDA, and others globally.

• Experience in supporting global development initiatives.

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

🏝️ Benefits

• 1-Year Contract

• Potential for Extension

• Remote work arrangement