Safety Physician -Safety Surveillance & Medical Safety
We are seeking an experienced physician to lead our Safety Surveillance and Medical Safety team as we continue to expand our Vigilance capabilities. This strategic role will manage product benefit-risk profiles, oversee safety data analysis, and guide safety signal investigations.
Key Responsibilities
* Provides strategic patient safety input on drugs/medical devices in the pre and post marketing setting
* Leads the safety strategy for regulatory communication and provides oversight of higher-level documents to support submission activities
* Perform medical review and assessment of adverse event (AE) and serious adverse event (SAE) reports
* Write/review aggregate reports (e.g. PSUR, PBRER, DSUR, and ASR), Benefit Risk Assessments and Risk Management Plans
* Provide clinical expertise for safety signal detection, evaluation, and risk management
* Review and contribute to clinical study protocols, investigator brochures, and informed consent forms with regards to safety content
* Contribute to safety sections of regulatory submissions and responses to health authorities
* Collaborate with cross-functional teams including clinical development, regulatory affairs, medical affairs, and vigilance operations
* Support the establishment and maintenance of pharmacovigilance systems and procedures in compliance with global regulations (e.g., FDA, EMA, ICH
* Provide medical guidance for safety data collection and analysis during clinical trials and post-marketing surveillance
* Assist in the preparation and presentation of safety data at internal and external meetings, including Safety Review Committees or Data Monitoring Committees
This is list is not exhaustive.
Requirements
* Degree in medicine and experience as a physician in Life Science space or academic clinician
* Minimum 8 years of experience in pharmacovigilance, drug safety, or clinical development within the pharmaceutical or biotechnology industry Strategic leadership of complex drug projects
* Knowledge of global PV regulations (FDA, EMA, ICH guidelines
* Strong analytical and critical thinking skills with the ability to interpret complex clinical data
* Excellent communication skills, both written and verbal (English)
* Proficient in safety databases (e.g., Argus) and Microsoft Office tools
* Share our PIPE values (People, Innovation, Passion, Excellence)
#J-18808-Ljbffr