This is a part-time position in Drug Safety and Pharmacovigilance (DSPV) which report to the CMO. He/she will perform periodic safety signaling, as well as perform individual and aggregate case review with support from an external partner. The successful candidate will provide adequate Sponsor oversight for all drug safety and pharmacovigilance activities for all sponsored clinical studies.
Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
Participate in preparation of Informed Consent Forms to ensure that adequate safety information is provided to study participants.
Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
Ensure compliance with worldwide regulations for the reporting of adverse events.
Monitor activities of CROs/business partners to ensure adherence and compliance with applicable Safety Monitoring Plans and other contractual agreements.
Collaborate with Medical Director and CMO, as well as Clinical Development Operations and vendor clinical staff who provide medical and/or monitoring support for ongoing clinical trials
Participate in the cross-functional program team meetings and safety oversight meetings that manage the overall benefit/risk profile of the compound.
Contribute to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
Contribute to preparation and review of responses to health authority queries as well oversee aggregate safety reports such as Development Safety Update Reports (DSURs) and Periodic Benefit/Risk Evaluation Reports (PBRERs) in collaboration with external safety vendor
Support the completion of Clinical Safety Reports (CSRs) by reviewing safety data, patient narratives, and safety sections of the documents.
Contribute as needed to the preparation for Data Safety Monitoring Board meetings.
Leads PV inspection readiness with the CMO and coordinates global inspection readiness activities for PV inspections of global products.
Provide Safety Reporting training at investigator meetings
Master’ s degree in relevant field (e.g. Life sciences) or equivalent combination of education and experience.
5 years’ experience in Pharmacovigilance compliance in the pharmaceutical industry.
Prior experience contributing to protocol, IB, and ICF development/updating
Prior experience writing CSRs.
Knowledge of ICH, US & EU regulations and requirements for Pharmacovigilance.
Willingness to be very “ hands-on” in a fast-paced work environment.
Experience working with vendors is strongly preferred.