Sr. Medical Safety Surveillance Officer

Gaithersburg, MD, US
Mar 19, 2021
Required Education
Position Type
Full time
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.

This position is responsible for overseeing the activities of the Drug Safety & Pharmacovigilance 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 Sr. Manager, Sr Safety Surveillance Officer provides medical and/or operational assessments of all Pharmacovigilance issues of all phases of clinical trials and post-marketed reports to ensure subject safety and accurate interpretation of results. This position will report to the Director, Safety and Pharmacovigilance.
Essential Functions
• Assessment and oversight of activities for monitoring adverse event reports for potential drug-safety related issues and provides recommendations when potential issues are identified.
• Collaborations with Clinical Research & Development and Medical Affairs and applicable functional specialists to identify, evaluate and manage safety signals.
• Supports signal management, safety surveillance and risk management plans for drug development programs.
• Prepares expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report etc).
• Provides expert functional advice as well as assistance to other functions as needed.
• Reviews, updates or writes company SOPs related to Pharmacovigilance and safety reporting to ensure their compliance with EMA, ICH, and FDA guidelines.
• Assists 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.
• Provides 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.
• The preparation of Company Core Safety Information (CCSI) for marketed and investigational products and the Company Core Data Sheet (CCDS).
• Facilitates and ensures communication with departments that may be involved with receiving, investigating, or reporting AEs.
• Collaborates with and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives.
• Collaborates with corporate partners in order 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.
• Assists Data Management with MedDRA and WHO dictionary codes and other medical perspective.
• Performs a 100% review of the case information entered in the safety database to ensure quality and accuracy of the data entered such as: updates and corrects ,MedDRA and WHO dictionary codes.
• Completes the Company Medical Assessment.

Education, Experience & Skills
• MD degree is required.
• Three or more years of relevant experience in Safety and Pharmacovigilance in pharmaceuticals/biotech is required.
• 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.
• Able to analyze signal detection and trends for specific product
• 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, RMPs, and RSI required.
• Proficiency with standard desktop computing programs (e-mail, Word, Excel) and relational databases required.

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.

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