Apply on Employer Site

Axsome Therapeutics, Inc. · 2 months ago

Pharmacovigilance Scientist

New York, NY

Full-time

Onsite

Senior Level

$150K/yr - $185K/yr

5+ years exp

Axsome Therapeutics is a biopharmaceutical company dedicated to advancing treatments for central nervous system conditions. The Pharmacovigilance Scientist will establish and execute pharmacovigilance systems, support safety surveillance, and collaborate with cross-functional teams to ensure effective safety monitoring and compliance with regulatory requirements.

BiopharmaBiotechnologyTherapeutics

Responsibilities

Assist safety physician to enhance safety surveillance and signal detection by monitoring and analyzing safety data from various sources to identify potential safety signals or trends related to investigational and marketed products

Contribute to the creation and execution of risk minimization measures to mitigate identified risks

Support the preparation pharmacovigilance aggregate safety reports (e.g., PADER, PSURs, DSURs) to regulatory authorities to meet compliance requirements

Collaborate with PV physician/PV operations and key stakeholders to request/receive applicable sections of the report

Provide training and guidance to other functions to address ad hoc questions and issues

Ensure timely finalization of the reports to meet the submission timelines of relevant health authorities and other external stakeholders

Collaborate and communicate with cross-functional teams to ensure effective safety monitoring and communication

Support the safety review team (SRT) and coordinates all safety topic discussion and documentation

Ensure appropriate stakeholder representation and input at SRT

Ensure all data is appropriately compiled and presented at SRT for team review

Liaise with SRT chair to facilitate communication and support for decisions resulting from the SRT (e.g. update of RMPs, labeling, regulatory notifications etc.)

Contribute to clinical trials by providing safety input and reviewing documents such as Clinical Study Reports (CSRs), protocols, and investigator brochures (IB), ICF etc

Provide support for the processing of individual case safety reports (ICSRs) and ensure data accuracy and completeness for investigational and marketed products

Support the PV SOP updates

Oversee vendor safety process, e.g., signal detection, validation and assessment

Participate in audit/inspection preparedness activities and provide support during regulatory inspections in collaboration with team members

Participate in new study initiation to ensure PV requirements are met including but not limited to safety reporting, query resolution, SAR reconciliation, un-blinding process, and safety reporting training

Evaluate and improve current PV processes, as needed, to strengthen medical surveillance and risk management process ensuring alignment with best practices

Qualification

Pharmacovigilance experienceSignal detectionRisk managementCase processingRegulatory requirementsICH guidelinesSafety database experienceAnalytical thinkerPlanningOrganizationCommunication

Required

Master's degree in health-discipline or equivalent required, RN, R.Ph, or Pharm D degree is highly preferred

5+ years of progressively responsible Pharmacovigilance experience in a pharmaceutical, biotechnology, or related environment with focused experience in signal detection, safety surveillance, risk mitigation and risk management

Extensive experience in case processing, regulatory requirements of ICSRs, MedDRA, WHODD, project management

Must demonstrate the ability to draft reports, business correspondence, and procedures, and to effectively present information and respond to questions from internal and external stakeholders, both domestic and international

Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Knowledge of ICH E2B(R2) and (R3) specifications and entry guidance

Knowledge of global pharmacovigilance reporting rules and timelines, including but not limited to Health Canada, FDA and EMA

Knowledge of relevant food and drug administration (FDA), European union (EU) and international conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance

Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc

Experience with clinical and/or post-marketing case assessment, including medical terminologies, MedDRA and WHO DD coding and narrative writing

Experience with safety database is required; ARISg is a plus but not mandatory

Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members

Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines

Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations

Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects

Excellent verbal and written communication and skills

Excellent in detailed-oriented tasks