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Pharmacovigilance Quality Assurance Manager

Current Employee? Job ID 17000SC0

PURPOSE AND SCOPE:

Responsible for overseeing all aspects of adverse event case processing and reporting for assigned investigational and marketed products. Also responsible for implementing and coordinating safety surveillance procedures for FMCRTG products. May serve as a liaison to external contract safety providers, manufacturing and other company personnel for safety issues. Works in collaboration with colleagues from PMS, Regulatory Affairs, Quality, Medical Affairs and Medical Informatics.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Ensures corporate compliance with adverse event reporting requirements; interprets the medical significance of all incoming safety information.
  • Actively coordinates with Director PV Systems Operations in the daily management and execution of PV operations.
  • Provides oversight for the AE reporting activities for delegated products and/or projects.
  • Serves as a Team Leader within the pharmacovigilance department supervising (Drug Safety Specialists and PV Principal Scientists) to validate data entry for preparation of ICSR’s in Aris- G and overall responsible to ensure all aggregate reports, ad-hoc internal and external safety queries preparations are carried out with high quality as per good PV practices.
  • Reviews incoming adverse event (AE) information to determine required action based on internal policies and procedures including identifying follow-up on clinically important adverse event reports.
  • Ensures corporate compliance with international adverse event reporting requirements for delegated products.
  • Supports the PV Physician as a lead for signal detection/safety monitoring activities which involves extracting relevant line listings of all AE’s from the PV system through MedDRA queries and present safety data to internal stake holders monthly PQTF meetings, as needed
  • Initiates processing and revision of all PV SOP’s and WI for efficient PV practices, as per regulations 
  • Supports the PV Physician in the preparation of relevant safety documents. This includes writing detailed safety analyses and summaries including signal evaluation reports; regulatory reports such as US periodic adverse event reports (PADER) and periodic safety update reports (PSUR).  In addition, guides the Principal PV Scientist in the preparation of other relevant documents such as pharmacovigilance plans and regulatory approval filing documents.
  • Ensures compliant exchange of safety data between FMC-NA and it’s other partners.
  • Collaborates with the contract service providers for all interlinked PV processes.
  • Assists the PV Physician to co-chair the Drug Safety Review Board meetings, as needed
  • Monitors the safety profile of delegated products and collaborate with the Head pf PV, Vice President, Drug and Device Safety Officer to assist in recommending appropriate action including labeling amendments and risk management programs when warranted.
  • Evaluates the clinical implications of safety data from literature and other information sources in order to establish the safety profile of drugs to manage the risk to patients.
  • Participates in the authoring of periodic safety update reports
  • Collaborates with contract service providers for case processing aggregate reporting and quality management activities.
  • Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues
  • Participates in regulatory inspections and audits
  • Provides training to staff to improve efficiencies on work processes
  • Participate in regulatory inspections and company audits units for
  • Develop relationships with and capture drug safety information from key groups
  • Ensures compliant exchange of Safety Data Exchange between FMC-NA partners and affiliates
  • Takes a lead in preparation of Regulatory PV inspections and Audits to ensure all PV procedures at FMC-NA are fully compliant with Good Pharmacovigilance practices and prepares responses to PV audit findings.
  • Assists with various projects as assigned by a direct Supervisor.
  • Train new hires on safety database processes.
  • Other duties, as assigned

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.



PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION:

  • RN with extensive PV experience

EXPERIENCE AND REQUIRED SKILLS:

  • PV experience in renal therapeutic area would be considered an added value
  • Pharmaceutical industry experience and pharmaceutical industry safety surveillance experience preferred. 
  • Knowledge of regulatory adverse event reporting requirements preferred. 
  • Familiarity with safety databases, 15-day safety alerts, submissions of safety updates to the FDA, Risk Evaluation and Mitigation Strategies FDA Industry Guidelines, ICH Guidelines, Drug Risk Management Plans, Knowledge of GXP Scope (Good Pharmacovigilance Practice).
  • Preferred minimum of 10 years total experience in US and/or international Pharmacovigilance/drug safety, or equivalent relevant clinical development experience in pharmaceutical drug development.
  • Must have demonstrated working knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance’s related to Pharmacovigilance and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug and device safety.
  • Has the capacity to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Must have excellent, concise writing skills, including excellent communication, interpersonal skills and experience in working in multidisciplinary teams.
  • Has the ability to work independently with minimal supervision, multi-task with attention to detail, is able to manage multiple projects under tight deadlines, independently identify problems and effectively offer solutions.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Current Employee?