About the Company
Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. We are dedicated to pioneering innovations that address the world’s most pressing health challenges.
Job Description
We are seeking a highly motivated and detail-oriented Drug Safety Chemist with a strong focus on Regulatory Affairs to join our dynamic team. This role is pivotal in ensuring the safety and compliance of our pharmaceutical products by meticulously analyzing and reporting adverse events, and collaborating closely with regulatory bodies. The ideal candidate will possess a solid background in chemistry, pharmacovigilance, and a comprehensive understanding of global regulatory requirements. This position offers Work From Home (WFH) options, emphasizing flexibility while maintaining high standards of regulatory compliance.
Key Responsibilities
- Conduct thorough scientific review and assessment of adverse event reports from various sources, ensuring accuracy and completeness.
- Perform root cause analysis for safety concerns and contribute to risk management strategies.
- Prepare and review aggregate safety reports (e.g., PSURs, DSURs) for submission to regulatory authorities.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and quality assurance, to ensure timely and accurate safety data exchange.
- Monitor global pharmacovigilance regulations and guidelines, ensuring company practices remain compliant.
- Participate in the development and maintenance of drug safety SOPs and training materials.
- Respond to inquiries from regulatory agencies regarding drug safety matters.
- Utilize drug safety databases and other relevant software for data entry, analysis, and report generation.
Required Skills
- Bachelor's degree in Chemistry, Pharmacy, or a related life science field.
- Minimum 4 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
- Strong understanding of global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines).
- Proficiency in adverse event case processing and safety database utilization (e.g., Argus, ArisG).
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills.
- Ability to work independently and as part of a remote team.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Qualifications
- Master's degree or Ph.D. in Chemistry, Pharmacology, or a related field.
- Experience with regulatory submissions and direct interaction with health authorities.
- Certification in Pharmacovigilance or Drug Safety.
- Experience in risk management plan development and implementation.
- Familiarity with medical coding dictionaries (MedDRA, WHO-DD).
Perks & Benefits
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Generous paid time off (PTO) and holidays.
- Flexible work arrangements and WFH options.
- Tuition reimbursement and professional development opportunities.
- Employee assistance program.
- Life and disability insurance.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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