Job Purpose
This role will have the medical safety expertise to perform obligatory safety functions with oversight from global drug safety lead. Ensuring safety of products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.
Responsibility
- Lead safety-related activities including signal, benefit-risk evaluation and risk management activities for assigned projects.
- Oversee handling of safety issues and implementing risk mitigation activities, and propose systemic solutions.
- Effectively collaborate with Pharmacovigilance and cross-functional teams for safety assessment, ongoing surveillance, and related communication.
- Provide guidance, oversight, and training around safety to relevant stakeholders.
- Perform medical review of SAEs, SUSARs and aggregate safety data from all sources.
- Lead the development of safety risk management plans, safety components of IND/NDA/MAA filings, annual safety reports.
- Provide inputs to different documents (e.g. trial protocols, amendments and plans; clinical trial reports and etc.) based on review
- Prepare relevant documentation (e.g. benefit/risk sections of aggregate reports; safety summaries) and Q&As as per regulatory requirements
- Develop and contribute for IND/BLA safety deliverables and regulatory responses
- Develop and contribute for safety surveillance SOPs, participate in PV audit and inspections
Requirements:
- MD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
- Experience in pharmaceutical or biotech industry working with Phase I III clinical trials, experience in Oncology.
- Minimum requirement: 7+ years experience in in drug safety/pharmacovigilance physician in clinical development.
- Oncology experience and clinical development experience strongly preferred.
- Experience with global PV regulatory environment (regulations, initiatives, standards, GVP).
- Work collaboratively and lead cross-functional teams.
- Good interpersonal and ownership.
- Hybrid Working