Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The VP, Safety and Pharmacovigilance collaborates with the Clinical, Regulatory and Medical Affairs departments to drive the effective and efficient operation of all aspects of safety and pharmacovigilance for the enterprise and across all Emergent portfolio of products. This position is responsible for establishing the safety and pharmacovigilance (PV) strategy in conjunction with development and commercial objectives.
This includes leading all pre- and post-marketing safety, PV and risk management activities. The incumbent in this position must effectively interface cross-functionally at all levels in the organization as well as external regulatory authorities. He/She oversees and is responsible for the integration of pre-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated and proactive approach to risk management.
The VP Safety and PV is a member of the Clinical-Medical-Regulatory Leadership Team (CMR-LT) as well as the Enterprise Senior Leadership Team (SLT). He/She is responsible for corporate oversight as it pertains to the execution of clinical study and commercial product safety strategies, as well as managing the organizational planning, budget and operations of the department.
- Manage daily operations of the Pharmacovigilance group, including receipt and processing of adverse events and medical inquiries
- Supervise the activities and development of Pharmacovigilance personnel
- Develop and manage annual department budget
- Develop Safety Data Exchange Agreements with Contract Safety Organizations
- Oversee pharmacovigilance activities, including the entry of all adverse event data into the Argus database and the preparation of tracking and trending reports
- Chair all Safety Committee meetings
- Oversee compliance activities of the Pharmacovigilance group, including submission of 15-day reports and annual safety reports. Ensure that Pharmacovigilance activities and procedures are maintained in compliance with all U.S. and global regulations
- Establish key performance metrics to measure compliance and data quality
- Serve as the Pharmacovigilance subject matter expert for internal audits and FDA and global regulatory inspections
- Serve as the main contact for the off-site database hosting company, which includes oversight of the Argus/MedDRA upgrades
- Oversee the work of the EU QPPV to ensure global pharmacovigilance compliance
- Responsible for oversight of global drug safety processes and activities
- Supports all labeling and promotional review committees and activities
- Responsible for management of external vendors
- Oversee the quality of all drug safety programs and drug safety deliverables
- Directs the medical assessments of all adverse event findings to the regulatory authorities, including but not limited to individual case safety reports (ICSRs), INDs, NDAs, annual report summary statements, and Periodic or Developmental Safety Update Reports (PSURs/DSURs/PBRERs).
- Directs the creation and maintenance of company core safety information and communication
- Responsible for all processes and operating procedures to ensure compliance with appropriate regulations and quality standards
- Responsible for drug safety surveillance and ensures safety of drug development activities in compliance with regulatory requirements and company standard operating procedures
- Drives safety updates and initiatives based on data from signal detection, clinical practice, or scientific research.
- Provides guidance for risk-benefit evaluations for any applicable RiskMAPs/REMS obligation and guides risk management plans for development and commercial products.
- Provide support for the preparation of clinical protocols, investigator brochure, clinical study reports, integrated clinical and statistical summary reports, journal articles, and other study documents
- Provides guidance with adverse event and drug coding, serious adverse event collection and analysis.
- Oversees and guides remediation of any Pharmacovigilance deficiencies cited during regulatory or internal audits.
- Establish safety and pharmacovigilance intelligence and communication network
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.
Education, Experience & Skills
- MD with 15 years of or more pharmacovigilance, clinical, medical, regulatory and quality experience on a global level
- Experience with Argus Safety or similar product database
- Proficient understanding of epidemiology and statistics
- Strong oral and written communication skills
- Strong record of effective organizational and people management
- Excellent analytical skills with an ability to critically interpret and use scientific and clinical data to manage risk assessment
- Demonstrated ability to utilize effective critical thinking and problem-solving skills
- Effective collaboration with other departments
- Communicates effectively in a matrix environment
- Ability to manage multiple tasks with deadlines in a fast-paced working environment
- Experience in regulatory requirements and guidelines pertaining to drug safety
- High attention to detail and accuracy
- Leadership experience dealing effectively with cross-functional groups with demonstrated cross-functional teamwork, verbal and written communication skills
- Strong commitment to business ethics
- Must understand medical terminology and medical coding using MedDRAOffice environment; national and international travel required as part of the role
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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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.