PatientsLikeMe is a patient network that improves lives and a real-time research platform that advances medicine. Through the network, patients connect with others who have the same disease or condition and track and share their own experiences. With 450,000+ members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 70 peer-reviewed research studies.
In the course of sharing their experiences, advice, and evaluations of treatments (including drugs, procedures, equipment, and supplements), some patients will indicate they have experienced an adverse event. As a member of the Research, Development, Informatics, and Policy department, the drug safety manager is responsible for the organizational strategy, goals, and objectives related to pharmacovigilance activities. We need you to lead PatientsLikeMe’s pharmacovigilance activities including all aspects of adverse event monitoring, evaluation, and submission to our clients, partners and the FDA. This provides a unique and exciting opportunity to contribute new knowledge to patient safety, pharmacovigilance, and health outcomes research.
- Implement and direct the company’s pharmacovigilance processes, ensuring that standard operating procedures (SOPs), guidelines, and working practices are current and reflective of current process, procedures and regulatory/legal obligations.
- Ensure audit readiness in collaboration with partners, to include:
- Support and assistance during regulatory/key customer inspections
- Consultancy assistance with inspection observation responses, and
- Monitoring and follow-up closure of regulatory inspection/key customer corrective actions
- Implement and oversee the company’s records management program for safety data.
- Continue to upgrade our platform’s existing AE system to ensure compliance with our partner’s requirements with minimal burden to our users.
- Determines resourcing requirements needed for pharmacovigilance monitoring across organization.
- Participate in intradepartmental and interdepartmental cross-functional project teams
- You have a clinical (RN/MSN, PharmD, MD/DO) degree or advanced degree in a related field with sound knowledge of biomedical sciences, clinical and therapeutic principles and clinical experience
- You have at least 3+ years of industry and/or regulatory experience in pharmacovigilance, including and experience with internal and external audits.
- You possess in-depth knowledge of US safety regulations and a working knowledge of non-US safety regulations, as well as AE reporting processes for single cases.
- You must be able to work independently at first, delivering reliable monitoring and liaising with our partners. Over time your role will include management to develop a new team within the company. The problem solving will vary from routine, to standard, to, occasionally setting precedent.
- Experience setting up a pharmacovigilance group and/or pharmacoepidemiology is a plus.