About Company
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Operating in over 100 countries, with millions of patients worldwide benefiting from our innovative medicines, we are driven by our purpose: to push the boundaries of science to deliver life-changing medicines. Our commitment extends beyond drug discovery to ensuring the safety and efficacy of our products throughout their lifecycle. We foster a culture of innovation, collaboration, and continuous learning, empowering our employees to make a tangible difference in global health. Join a team dedicated to advancing healthcare and making a profound impact on patients’ lives.
Job Description
We are seeking a highly meticulous and dedicated Pharmacovigilance Officer to join our dynamic team in Downtown, Boca Raton. This critical role is at the heart of our commitment to patient safety, involving the continuous monitoring, assessment, and management of the safety profile of our pharmaceutical products. As a Pharmacovigilance Officer, you will play a pivotal role in ensuring that all adverse event information is meticulously collected, analyzed, and reported in compliance with global regulatory requirements and internal standard operating procedures. You will contribute to the lifecycle management of our medicines, from clinical trials through post-market surveillance, by performing robust signal detection, risk-benefit assessments, and contributing to aggregate reports.
This position requires a deep understanding of pharmacovigilance principles, regulatory guidelines (e.g., FDA, ICH, EMA), and a proactive approach to identifying potential safety issues. You will be responsible for processing individual case safety reports, conducting quality control checks, and ensuring data integrity within our safety databases. Your expertise will be crucial in supporting regulatory submissions, responding to inquiries from health authorities, and collaborating with cross-functional teams including medical affairs, regulatory affairs, and clinical development. If you possess an unwavering commitment to patient well-being, a sharp analytical mind, and a desire to work in a leading biopharmaceutical company, this is an exceptional opportunity to advance your career and contribute to safeguarding public health.
Key Responsibilities
- Process individual case safety reports (ICSRs) from various sources, ensuring accuracy, completeness, and adherence to timelines.
- Conduct thorough causality assessment and medical coding of adverse events using standardized medical dictionaries (e.g., MedDRA, WHO-DD).
- Perform quality control checks on ICSRs and other pharmacovigilance documents to maintain data integrity.
- Contribute to the preparation and review of aggregate safety reports, such as Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
- Assist in signal detection and safety surveillance activities, including data mining and trend analysis.
- Ensure timely and accurate submission of safety reports to regulatory authorities worldwide.
- Participate in the development and maintenance of pharmacovigilance standard operating procedures (SOPs) and work instructions.
- Collaborate with internal departments (e.g., Clinical Development, Regulatory Affairs, Medical Affairs) to ensure seamless information flow and alignment on safety matters.
- Respond to pharmacovigilance-related queries from health authorities, investigators, and internal stakeholders.
- Support internal and external audits and inspections by providing necessary documentation and expertise.
- Stay current with global pharmacovigilance regulations, guidelines, and industry best practices.
Required Skills
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
- Minimum of 2 years of experience in pharmacovigilance/drug safety within a pharmaceutical company, CRO, or regulatory agency.
- Strong understanding of global pharmacovigilance regulations and guidelines (e.g., FDA, ICH, EMA).
- Proficiency in medical terminology and medical coding systems (e.g., MedDRA, WHO-DD).
- Experience with pharmacovigilance safety databases (e.g., Argus, ArisG).
- Excellent analytical skills and attention to detail.
- Strong written and verbal communication skills.
- Ability to work effectively both independently and as part of a cross-functional team.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Qualifications
- Advanced degree (PharmD, Master's, PhD) in a relevant scientific or medical discipline.
- Certification in Pharmacovigilance or Drug Safety.
- Experience with signal detection methodologies and tools.
- Knowledge of clinical trial safety reporting requirements.
- Familiarity with risk management plans (RMPs).
Perks & Benefits
- Comprehensive Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan with Company Match
- Generous Paid Time Off (PTO) and Holiday Schedule
- Life and Disability Insurance
- Employee Assistance Program (EAP)
- Tuition Reimbursement and Professional Development Opportunities
- Wellness Programs and On-site Fitness Facilities (where applicable)
- Employee Stock Purchase Plan
- Commuter Benefits
How to Apply
Interested candidates are encouraged to apply directly through AstraZeneca’s official careers portal. Please click on the application link below, search for ‘Pharmacovigilance’ roles, and submit your resume and cover letter detailing your relevant experience and qualifications. Ensure your application clearly demonstrates your alignment with the required skills and responsibilities.