Pharmacovigilance Physician

Title: Pharmacovigilance Physician (FTE)

Location: Fredrick, MD  (Hybrid- two days a week on-site)

Requirement: US License

 

Responsibilities:

The individual shall provide medical regulatory support for activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to investigational products.  Pharmacovigilance support includes but is not limited to the following:

-Provide continuous pharmacovigilance support to receive, assess, and escalate adverse event reports IAW regulatory timelines and sponsor SOPs including intake, triage, assessment, and reporting of adverse events, ensuring 24 hours per day, 7 days per week coverage, including holidays and weekends.

-Develop pre-market and post market safety plans.

-Surveillance plan(s) specific to products/protocols that include signal detection tools and templates necessary to implement the safety surveillance

-Develop and maintain safety management plan(s) that delineate the roles, responsibilities, processes, and timelines for safety activities and drives the execution of the safety related activities during a trial

-Establish Data Safety Monitoring Boards (DSMB)/Committees, which includes identifying members, developing, reviewing and finalizing the initial Charter and any revisions

-Schedule and coordinate DSMB/Committee Meetings (organizational, in-process, executive, and ad hoc), including a face-to-face initial DSMB/committee organizational meeting at a central location within the continental United States, and provide an agenda.

-Develop and prepare written DSMB meeting minutes for each meeting per SOPs

-Provide the DSMB/Committee Chair Recommendation(s) form, completed and signed by the DSMB/Committee Chair within 24 hours of the meeting conclusion, documenting the DSMB/Committee decisions and recommendations to the Safety Office

-Provide pharmacovigilance support that includes but is not limited to reviewing clinical protocols and associated documents, conducting literature searches, providing risk-benefit analyses, developing comprehensive risk mitigation plans, and writing white papers

-Provide pharmacovigilance guidance and subject matter expertise

-Receive, process, evaluate, and manage reported safety cases through electronic systems, such as Argus, which may include but are not limited to data entry and preparation of serious adverse event narratives, generating analyses of similar events, data element coding of event terms in the safety database utilizing the Medical Dictionary for Regulatory Activities and preforming quality control reviews of the entered data

-Monitor the safety mailbox at a minimum twice a day 7 days a week, to include weekends and holidays, for new incoming unexpected and related serious adverse events

-Triage safety reports, interpret clinical data, and perform regulatory evaluation for regulatory reporting purposes

-Track follow-up information /correspondence through to case closure

-Report serious adverse events to the FDA and other applicable regulatory authorities IAW 21 CFR 312.32 and 312.33, and ICH Guidelines

-Identify database cases eligible for archiving and assist with archiving all documents in compliance with government internal standards and regulatory guidelines

-Provide strategic input or oversight for regulatory documents including, but not limited to, Investigational New Drug application safety reports (MedWatch), annual reports, and final clinical study reports

-Notify the investigator(s) of safety information, including expedited serious adverse events, according to Government procedures and IAW 21 CFR 312.32 and 312.33 and ICH Guidelines

-Manage and process reported pregnancy cases through electronic systems, which may include but is not limited to data entry and preparation of narratives, generating and sending follow-up queries as appropriate until term, generating analyses of similar events, data element coding of event terms in the safety database utilizing the Medical Dictionary for Regulatory Activities dictionary and performing quality reviews of data entered into the electronic data management system and other systems as applicable

-Reconcile data and documentation in the Safety Database and the Clinical Database at a minimum annually before the annual report and before study database lock

-Develop and/or review protocol specific documents and clinical safety documents including but not limited to clinical protocols, informed consent forms, investigator brochures, data monitoring committee charters, safety management plans, safety surveillance plans, safety-related source document and other associated clinical safety documents

-Develop a protocol/product specific unblinding plan prior to the start of a clinical trial

-Work with clinical monitors and site staff to resolve issues and obtain needed documentation.

Must be a US Citizen or a full Green Card holder.