Drug Safety Lead
Overview
Precision for Medicine is hiring a Drug Safety Lead to join our global team. We can consider candidates working remotely in UK, Poland, Hungary, Romania, Serbia or Slovakia.
Responsibilities
- Interfacing with sponsors, vendors, and other internal team members in the area of safety/pharmacovigilance to assist in the design and implementation of safety collection tools, processes, and reporting systems.
- Participate in the assessment and set-up of a safety database to capture SAE data.
- QC of documents and safety reports when needed.
- Preparation and/or review of project specific safety reporting plans and medical coding plans.
- Preparation and/or review of safety training materials.
- Review of safety related budget tasks and activities.
- Develop and manage standard operating procedures and work instructions.
- Provide ongoing training and mentorship for Safety Specialists.
- Participate in audits and audit preparation, kick-off meetings, and investigator meetings.
- Participate in the CAPA management process.
- Participate in bid defenses for existing and potential clients.
- Assist departmental management with resource management and oversight.
- Serve as project manager for safety standalone projects.
- Lead departmental initiatives and cross-functional development activities.
- Support the generation of SAE/AESI queries and tracking including oversight in the query resolution escalation efforts.
- Provide input and review of responses to regulatory agency questions with regard to safety/pharmacovigilance activities.
- Assist clients and/or other departmental staff with safety-related reviews and other services.
Qualifications
- 5+ years Pharmacovigilance (PV) experience together with experience in a client facing role working as a lead.
- Must have experience working for a Clinical Research Organisation in Drug Safety.
- Clinical trial experience.
- Experience in budgets, allocating budgets.
- Experience with global safety database(s), SAE case processing, and safety reports generation.
- Working knowledge of MedDRA and WHODrug.
- Working knowledge of FDA safety regulations, ICH guidelines, and global regulations.
- Demonstrated knowledge of relevant regulatory agency(s) guidelines governing safety reporting and processing for clinical trial environments.
- Demonstrated knowledge of supporting internal audits, inspection readiness and regulatory agency inspections for clinical trials including BLA or NDA inspection support.
- Excellent communication and analytical skills (written and oral).
- Excellent judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
About Precision for Medicine Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our approach integrates clinical operations excellence with laboratory expertise and advanced data sciences to inform every step, from early development through approval, with embedded experience in oncology and rare disease. EEO and Accommodations Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, you may contact Precision Medicine Group at [email protected]. #J-18808-Ljbffr Salary: USD 72000 - 108000 per year Experience: 5 years required