Sr Medical Director, Safety Science & Benefit-Risk Management
- Emergent BioSolutions
- Gaithersburg, MD
- Start date
- Mar 31, 2023
- Administration, Clinical, Manufacturing & Production
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
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 directing and overseeing medical safety science and benefit-risk management of the Drug Safety & Pharmacovigilance department. The Medical Director/Sr Medical Director, Safety evaluation and benefit-risk management provides medical oversight of safety issues of all phases of clinical trials and post-marketed products to ensure patient safety and accurate interpretation of results. This position will report to the VP, Safety and Pharmacovigilance.
- Provides leadership and collaborates with Scientific Research & Development, Quality, Medical Affairs and applicable functionals to identify, evaluate and manage safety signals and safety related issues.
- Leads the development of safety surveillance, signal detection and management, benefit-risk assessment and management of company products.
- Lead and manage the safety physician and safety scientist teams.
- Lead and support safety related interactions with regulators, prior IND/NDA submission experience.
- Provides leadership and assists in the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report etc).
- 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.
- Facilitates and ensures communication with departments that may be involved with receiving, investigating, or reporting AEs. Provides expert functional advice as well as assistance to other functions as needed.
- Collaborates with and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives.
Education, Experience & Skills
- Advanced degree Required (e.g., MD, DO) or other international equivalent. Additional training in epidemiology and/or statistics is a plus.
- Ten or more years of relevant experience in Safety and Pharmacovigilance in pharmaceuticals/biotech is required.
- Strong verbal and written communication skills. Excellent analytical skills.
- Prior management experience 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.
- 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.
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.
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.
Stock Symbol: EBS
400 Professional Drive
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