Senior Manager, Pharmacovigilance Quality

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I.    JOB SUMMARY 

The Senior Manager Pharmacovigilance Quality:  

Provides a leadership role in implementing Pharmacovigilance (PV) quality management system and in streamlining current processes, with all the characteristics which are considered to produce outcomes relevant to the objectives of pharmacovigilance and safety of emergent Products and facilitates continuous improvement of these processes. 

Supports developmental programs, including both early and late-stage development as well as current marketed Products to Comply with Good Pharmacovigilance Practices (GVP).

Manages pharmacovigilance quality oversight activity in collaboration with core team members in Clinical (GCP), Regulatory Affairs (RA), and relevant Project/Program Management groups to ensure quality and GPV compliance.  

II.    ESSENTIAL FUNCTIONS
•    Serve as partner with the pharmacovigilance/safety team to ensure PV compliance. This is achieved through: 
•    Overseeing the functioning of the PV systems in all relevant aspects, including its quality system (e.g., standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance).
•    Developing, implementing, maintaining, and improving relevant quality and operational systems.

•    Working with the Pharmacovigilance Team to Lead Process improvement initiatives to ensure processes/procedures meet organization and Quality requirements and standards.

•    As Global PV quality lead, working with the Global Patient Safety and Evaluations team and theSenior Medical and Pharmacovigilance staff to provide Quality oversight on signal detection and risk management activities for designated global/regional product(s).

•    Acting as a strategic compliance resource providing support and guidance on the interpretation of regulations and industry best practices.

•    Monitoring regulations for new and emerging trends and assessing impact to Emergent’s operations.

•    Reviewing and assessing changes to global regulatory requirements and industry best practices and facilitating implementation through new or revised processes.

•    Establishing and maintaining the marketing authorization holder’s pharmacovigilance system with sufficient authority to influence the performance of the quality system and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements.

•    Working with Clinical and PV groups to develop and maintain standards for operations. 

•    Providing Quality input on relevant PV procedures and processes to ensure compliance with regulations and industry standards.
•    Provide QA support in inspection preparation and host PV related regulatory inspections, including pre-inspection and follow-up activities related to PV inspections. 
•    Develop and manage internal audit schedule and conduct internal systems audits of Pharmacovigilance (GVP) systems, seeing audit observations through to completion.
•    Conduct external vendor qualification/re-qualification audits of PV/Safety related vendors as needed to support business needs and ensure compliance.
•    Negotiate Quality Agreements with vendors performing GVP activities.
•    Support operations through the conduct of in-study audits (GVP).
•    Manage and/or actively support for-cause activities.
•    Review of medical assessments as needed to support clinical related investigations in support of IP. 
•    Review of Aggregate Reports in support of Emergent Commercial and Clinical products as well as review of Emergent Regulatory filings, Information requests and related reports and technical documentation for compliance with regulations, guidance, and industry standards.
•    Network across applicable Emergent sites/Functions/Teams and internal stakeholders to positively influence the compliance health of these operational areas and to drive quality decisions as part of the project team.
•    Maintain Quality performance using Key Performance Indicators used to continuously monitor the performance of pharmacovigilance activities by establishing, monitoring, tracking and reporting metrics which measure the health of the quality and operational systems. 
•    Establish, monitor, and track processes and metrics which measure the level of risk of studies, programs, and sites. 
•    Ensure visibility to and manage awareness of any noted deviations, issues, or deficiencies by escalating to management.
•    Participate in integration or due diligence activities as required/requested.
•    Mentor and coach Global Pharmacovigilance Staff as needed.
•    Develop and deliver GCP and GVP training.
•    Prepare and provide budget estimates to management, support budget updates, prepare Quality budgets as inputs to Requests for Proposals.
•    Ensure records to demonstrate that deficiencies and deviations from the established quality system are monitored; that corrective and preventive actions have been taken; that solutions have been applied to deviations or deficiencies; and that the effectiveness of the actions taken has been verified. 

•    Ensure the archiving of records created because of pharmacovigilance processes which demonstrate key steps for the defined procedures have been taken. 

•    Review documentation of the quality system at regular intervals, with the frequency and the extent of the reviews to be determined in a risk-based manner.

•    Review standard operating procedures and work instructions, deviations from the established quality system, audit and inspections reports as well as the use of the indicators referred to above. 

•    Ensure validation status of the database, including any failures that occurred during validation and the corrective actions that have been taken to address the failures.

•    Manage as per standard change control procedures any significant changes that are made to the database (e.g., changes that could have an impact on pharmacovigilance activities).
•    Senior manager PV Quality has access to the pharmacovigilance system master file (PSMF) and authority to ensure and to verify that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system.
•    Other duties as assigned.

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Minimum Bachelor of Science (B.S.) degree
•    Over 7 years of experience in the pharmaceutical industry, preferably in Clinical Quality Assurance and pharmacovigilance, in progressively responsible Quality or pharmacovigilance/safety roles
•    3-5 years leadership experience conducting and managing GCP quality assurance or pharmacovigilance audits. 
•    Demonstrated understanding of GLP, GCP, and GVP requirements for compliance with domestic and international regulations including those of the US FDA, Health Canada, and EMA in biologics, vaccines and/or devices
•    Experience providing Quality Assurance, Clinical Operations or PV operational oversight in a minimum of two of the following disciplines (GLP, GVP, GCP) 
•    Strong interpersonal, verbal and written communication skills including technical writing skills.
•    Must understand a variety of quality systems that support the product development lifecycle and post marketing arena.
•    Solid problem solving and critical thinking skills.
•    Previous experience in preparing for and hosting/responding to regulatory health authority inspections.
•    Ability to lead projects with minimal supervision required; to work independently and in a team-based environment.
•    Ability to effectively plan, organize, monitor, execute, and measure success of a project.
•    Ability to anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall program.
•    Demonstrated ability to develop and implement business processes and process improvements.

IV.    PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
 

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.