Sr Manager, Safety Quality & Compliance

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.
JOB SUMMARY
The Sr. Manager of Patient Safety Quality and Compliance will support and lead preparation, delivery, and responses to GVP inspections and audits of the Pharmacovigilance system and coordinate Patient Safety input to GCP and GMP inspections. The Sr. Manager is a key role and will be responsible for promoting inspection readiness, supporting Quality Events and Quality actions (such as deviations, root cause analysis and CAPA plans and effectiveness checks), monitoring quality and compliance with associated Key Performance Indicators (KPIs), and driving continuous improvement across the company pharmacovigilance system. The position will directly report to the Director/Sr Director of Patient Safety Quality, Compliance, and Alliance (SQCA).
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Responsibilities include but not limited to:

• Responsible for maintaining and monitoring regulatory reporting compliance and leading PV compliance oversight activities, including but not limited to; case quality, management and reporting, quality and timely submission of periodic safety update reports, adherence to risk management plan commitments, adherence to XEVMPD compliance and including the development and monitoring of Key Process Indicators (KPIs).
• Partner with members from the Quality Department to align compliance processes and procedures with existing or required quality processes.
• Participate in both departmental and cross-functional meetings and initiatives to increase awareness, education, training, and leadership for patient safety/pharmacovigilance compliance.
• Coordinate departmental activities for GVP, GCP and GMP audits/inspections both globally and with local affiliates, promote inspection readiness.
• Overseeing the functioning of the PV systems in all relevant aspects, including its quality system (e.g., standard operating procedures, contractual arrangements, database operations, signal detection and risk management activities, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic safety update reports, audit reports and training of personnel in relation to pharmacovigilance).Partners with the Director, SQCA to oversee the quality of pharmacovigilance activities in collaboration with the core team members in Global Clinical (GCQ), Clinical Development (CD), Regulatory Affairs (RA), Medical Affairs (MA), and other relevant groups to ensure inspection/ audit readiness.
• Work as liaison between Quality Department and Patient Safety stakeholders to ensure a professional and beneficial relationship with Patient Safety vendors, establishing an oversight mechanism to accesses both the quality and compliance of the contracted deliverables.
• Establish/support patient safety/PV intelligence to keep up with regulatory and industry standards in conjunction with Regulatory Intelligence department.
• Collaboration with Global Clinical/Pharmacovigilance Quality to drive a culture of continuous improvement, high performance, flexibility, and quality emphasizing a “can do” attitude across Pharmacovigilance system.
• Work closely with all stakeholders in the Pharmacovigilance Department, and related Emergent departments to understand existing processes and procedures and identify gaps and opportunities for improvement in both effectiveness and efficiency.
• Identify and ensure appropriate and applicable training of pharmacovigilance staff (and vendors) to ensure compliance with good pharmacovigilance practices; provide training to Patient Safety and other functional groups, including commercial colleagues, in key areas of expertise.
• Establish/support tracking system for aggregate reports, RMPs, and other safety related documents to ensure inspection readiness.
• Provide leadership related to the action plan and resolution of inspection/audit findings and/or corrective actions; preventative actions (CAPAs).

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s degree in the science field, with emphasis in biomedical or health sciences; advanced degree is strongly preferred.
• Minimum 5-8 years relevant experience in pharmacovigilance, regulatory or QA,with at least 5 years of experience and proficiency in the following areas:
• Experience with Medical Devices strongly preferred.

Drug Safety/Pharmacovigilance
ARGUS global software database, with experience in end-to-end case processing
Development and implementation of compliance processes in a pharmacovigilance setting

• Proven ability to work independently and/or in a cross-functional, cross-cultural, and different time-zones in a virtual/remote environment.
• Ability to work in a fast passed highly matrixed organization.
• Excellent communication skills including written, verbal, listening and presentation skills.
• Experience with compliance and quality management systems including deviation/CAPA management, late case investigations, management of KPIs, management of PV documents and trainings, PV audits and regulatory inspections.
• Robust and sound knowledge of Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), and International Conference of Harmonization (ICH) regulations regarding drug development.
• Detailed and solution-oriented with the ability to ensure a high level of commitment to the overall success of the team, department, and organization.
• Strong leadership skills, including experience of leading project teams.
• Experience supporting regulatory inspections preferred.
• Proven knowledge of pharmacovigilance requirements strongly preferred.
• Proven medical knowledge and understanding to support safety reporting.
• Knowledge of QMS and continuous improvement methodologies

#LI-Remote
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.
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