Medical Director, Global Safety Physician

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

📋 Description

• Oversee medical evaluations and analysis of safety data derived from clinical trials, literature reviews, and various other sources.

• Work collaboratively with cross-functional teams to support clinical development initiatives, regulatory submissions, and global safety operations.

• Assist the clinical R&D team in monitoring pharmacovigilance service providers and partners.

• Stay updated on medical knowledge, as well as drug safety and pharmacovigilance regulations, practices, safety monitoring, and risk management strategies.

• Contribute medical safety insights and engage in safety monitoring, including the identification of safety signals and ensuring prompt evaluation and communication of confirmed signals.

• Offer input for aggregate safety reports, such as DSURs, PADERs, and PBRERs.

• Provide contributions to study protocols, amendments, safety plans, clinical study reports, eCRFs/CRFs, and TMFs.

• Manage both internal and external forums, including external Data Monitoring Committees and Safety Management Teams, for assigned products and studies.

• Collaborate with Medical Monitors, Clinical Research Scientists, and vendor clinical personnel for ongoing clinical trials.

• Contribute to the development and updates of Risk Management Plans.

• Assist in the creation of Standard Operating Procedures, Working Instructions, and other guiding documents.

• Address and resolve safety inquiries from health authorities and assist with regulatory agency audits and inspections.

• Provide safety guidance, oversight, and training to employees, CROs, and site investigators.

• Act as a subject matter expert for CRO vendors delivering drug safety and pharmacovigilance services.

• Educate and mentor teams on emerging safety topics, pharmacovigilance processes, technologies, and new regulations.

• Report directly to the Head of Medical Safety, Global Pharmacovigilance.

⛳️ Requirements

• A minimum of 5 years’ experience in Drug Safety/Pharmacovigilance within a pharmaceutical or biotech environment, CRO, or regulatory agency.

• Medical Degree (MD) from a recognized international medical institution.

• At least 3 years of residency training and experience in medical practice.

• Board certification as an Ophthalmologist with experience in drug discovery and clinical development is highly preferred.

• Strong familiarity with US and EU drug safety and pharmacovigilance regulations, CIOMS, and ICH guidelines.

• Demonstrated experience in medical safety evaluations, safety monitoring, and risk management efforts.

• In-depth knowledge and clinical acumen in safety signal management, medical reviews, aggregate safety assessments, and benefit-risk decision-making throughout clinical development and post-marketing products.

• Extensive familiarity with common safety databases (Oracle Argus Safety and/or Aris Global).

• Understanding of MedDRA coding.

• Experience in the medical review of ICSRs, including assessments of expectedness, causality, narrative evaluations, and analysis of similar events, along with benefit-risk assessments.

• Experienced in authoring aggregate reports (DSUR, PSUR/PBRER, PADER).

• Experience in preparing responses to regulatory authorities.

• Preferred experience in regulatory submissions and related activities.

• Proven ability to influence cross-functional teams and manage stakeholders as a global medical safety leader.

• Extensive experience in interactions with global health authorities and leading safety-related regulatory initiatives.

• Strong comprehension of global pharmacovigilance regulations and industry best practices.

• Capability to influence decision-making at cross-functional and executive levels and build effective partnerships across Patient Safety/Pharmacovigilance, Clinical Science, Regulatory Affairs, Medical Affairs, and Biometrics.

🏝️ Benefits

• Annual incentive bonuses

• Equity participation

• Health insurance

• Dental insurance

• Vision insurance

• 401(k)

• Paid time off

• Reasonable accommodations for individuals with disabilities