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.
This position is responsible for overseeing the activities of the Global Patient Safety and Epidemiology function and ensuring corporate compliance with all applicable US and foreign legal and regulatory requirements for adverse event reporting & safety management of medicinal products, both approved and in development. The Director, Safety Physician provides medical and/or operational assessments of all Patient Safety issues in all phases of clinical trials and post-marketed reports to ensure subject safety and accurate interpretation of results. This position will report to the Sr. Medical Director, Safety Science and Benefit-Risk Management.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Assess and oversee the activities for monitoring adverse event reports for potential drug-safety related issues and provides recommendations when potential issues are identified.
• Collaborate with Clinical Research & Development and Medical Affairs and applicable functional specialists to identify, evaluate and manage safety signals.
• Lead signal management, safety surveillance and risk management plans for drug development programs and post-marketed products.
• Chair the Safety Review Team.
• Collaborate with safety scientists to prepare expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc.).
• Provide expert functional advice as well as assistance to other functions as needed.
• Review, update, or write company SOPs related to Pharmacovigilance and safety reporting to ensure their compliance with EMA, ICH, and FDA guidelines.
• Assist in the preparation and review of safety section(s) of investigator brochures, protocols informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other documents.
• Provide medical expertise and contributions to pharmacovigilance activities and priorities such as: Ad-hoc safety information/reports for inquiry response to Regulatory Health Authorities safety queries as well as from senior management including safety documentation for licensure submissions.
• Prepare Company Core Safety Information (CCSI) for marketed and investigational products and the Company Core Data Sheet (CCDS),
• Lead the determination of Adverse Reactions section of the product label; leads and support the preparation and review of other safety relevant sections of the label.
• Facilitate and ensures communication with departments that may be involved with receiving, investigating, or reporting AEs.
• Collaborate swith and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives.
• Collaborate with corporate partners to ensure proper exchange of drug-safety data.
• Responsible for case reports (clinical trials and post marketing) submission to Regulatory Authorities in a timely manner.
• Assist Data Management with MedDRA and WHO dictionary codes and other medical perspective.
• Review of the case information entered in the safety database to ensure quality and accuracy of the data entered (i.e., updates and corrects MedDRA and WHO dictionary codes).
• Completes the Company Medical Assessment for ICSR.
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
• Advanced medical degree required (e.g., MD, DO) or other international equivalents. Additional training in epidemiology and/or statistics is a plus.
• A minimum of 3 years clinical practice after postgraduate training.
• Five or more years of relevant experience in Clinical Safety and Pharmacovigilance in pharmaceuticals/biotech is required. Medical Devices, Drug-Device combinations, or opioid antidote experience is a plus.
• Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU) Volume 10 clinical trials directive; Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines) required.
• Strong leadership, teamwork, and interpersonal skills, with experience in a matrixed environment.
• Proven ability to analyze data from various sources for signal detection and trends for specific products.
• Ability to process adverse event reports including medical analysis.
• Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and context applicable to safety surveillance activities required.
• Knowledge of MedDRA terminology and its application required.
• Experience in the preparation and authoring of pre- and post- aggregate safety reports (e.g., DSURs, PSURs), RMPs, and RSI required.
• Proficiency with standard desktop computing programs (e.g., Word, Excel, PowerPoint) and relational databases required.
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.
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.