About This RoleAs a Medical Director, Global Safety Physician, this individual will be responsible for leading medical assessment and interpretation of safety data from multiple sources, including clinical trials, and literature reports. The individual will be closely collaborating with cross functional teams in supporting all clinical development programs, regulatory filling, and global safety related activities. This individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
This role reports directly to the Head of Medical Safety, Global Pharmacovigilance.
Key Responsibilities - Provide medical safety input and participate in safety surveillance activities (e.g., identification of safety signals and ensure timely assessment and communication of confirmed safety signals).
- Provide input in the generation of aggregate safety reports (e.g., DSURs, PADER, PBRER).
- Provide inputs to different documents (e.g. study protocols, amendments and safety plans; clinical study reports; eCRFs/CRFs;TMFs)
- Manage internal & external forums (e.g. external Data monitoring Committees (DMCs); Safety Management Team) for assigned products/studies
- Collaborate with Medical Monitors and Clinical Research Scientists and vendor clinical staff as needed for ongoing clinical trials.
- Provide medical safety input in the development and/or updates of Risk Management Plans and the maintenance of these documents.
- Provide support and input to the development of Standard Operating Procedures, Working Instructions, and other guidance documents.
- Work closely with other Product Safety Leads and Head of Medical Safety to respond to and resolve safety questions from health authorities as well as regulatory agency's audits and inspections.
- Provide guidance, oversight, and training around safety to relevant stakeholders (e.g. internal employees, CROs and site investigators)
- Serve as a subject matter expert for vendors (CRO) that provide drug safety and pharmacovigilance services.
- Train and mentor teams on emerging safety aspects and PV processes, technologies, and new regulations
Qualifications - 5+ years' experience in Drug Safety/Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency.
- Medical Degree (MD) from a recognized international medical school with at least 3 years of residency training & medical practice experience. Board-certified Ophthalmologist with drug discovery and clinical development experience strongly preferred.
- Strong working knowledge of US and EU drug safety and pharmacovigilance regulations, CIOMS and ICH guidelines.
- Proven experience in medical safety assessments, safety surveillance and risk management activities. Extensive knowledge and clinical judgment in safety signal management, medical review, aggregate safety assessment and benefit-risk decision-making across clinical development and post-marketing products
- Extensive knowledge of common safety databases (Oracle Argus Safety and/or Aris Global), regulatory regulations, and MedDRA coding, medical review of ICSRs including expectedness assessments, causality assessments, narrative review and analysis of similar event and company comment statements including benefit-risk assessment.
- Experience with authoring aggregate reports (e.g., DSUR, PSUR/PBRER, PADER)
- Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related activities preferred.
Preferred Qualification - Demonstrated success in cross-functional influence and stakeholder management
as global medical safety leader
- Extensive experience interacting with global health authorities and leading safety-related regulatory activities
- Strong understanding of global pharmacovigilance regulations and industry best practices
- Proven ability to influence cross-functional and executive-level decision-making and build effective partnerships across Patient Safety/Pharmacovigilance, Clinical Science, Regulatory Affairs, Medical Affairs and Biometrics
Salary DisclosurePay Range: $180,000-240,000 USD
Salary offered will depend on candidate location, market rate adjustments, skills, and relevant experience.
Belite Bio provides a competitive total compensation package that includes base salary, annual incentive bonuses, equity participation, and a full benefit package (health, dental, vision, 401(k), and paid time off).
