Director, Pharmacovigilance Operations
- Emergent BioSolutions
- Gaithersburg, MD
- Start date
- Mar 24, 2023
- Clinical, Drug Safety/Pharmacovigilance, Manufacturing & Production
- Required Education
- 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 the operational 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, both pre-approved and approved products. This position reports directly to the VP of Safety and Pharmacovigilance.
- Manage daily operations of the Pharmacovigilance group, including receipt and processing of adverse events and medical inquiries
- Supervise the activities and development of Pharmacovigilance Specialists
- Develop and manage annual safety operation 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; preparation for monthly signal detection meetings
- Oversee compliance activities of the Pharmacovigilance group, including submission of 15-day reports and annual safety reports. Ensure that Pharmacovigilance activities and procedures and maintained in compliance with all U.S. and other local health authority regulations
- Serve as the Pharmacovigilance subject matter expert for internal audits and FDA inspections
- Serve as the main contact for the off-site database hosting company, which includes oversight of the Argus/MedDRA upgrades
- Work with the Head of Global Pharmacovigilance and EU QPPV to ensure global pharmacovigilance compliance
- 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.
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
• Health Science degree (i.e., PhD, PharmD, RN) in medical or related science field.
• Must understand medical terminology and medical coding using MedDRA
• Experience with Argus Safety, Empirica, or similar product database
• Basic understanding of epidemiology and statistics is a plus
• Strong oral and written communication skills
• Excellent analytical skills
• Eight or more years work experience in pharmaceutical industry in pharmacovigilance, five plus years in safety/PV operation. Prior management experience 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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