Pharmaceutical Safety Expert for Global Operations
6 days ago
Company Overview:
Mitsubishi Tanabe Pharma America, Inc. is a US subsidiary of Mitsubishi Tanabe Pharma Corporation in Japan, boasting a 300-year legacy.
The company has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing treatments for Neurology in Parkinson's (PD), Spinal Cord Injury (SCI), Immunology, and Oncology.
In the United States, MTPA launched rare disease treatments, such as RADICAVA injectables in 2017 and oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions to improve treatment environments for those with debilitating diseases.
Salary: $112,000 - $179,000 per year, plus benefits.
Job Description: As a Manager, Drug Safety Data, you will be responsible for managing and analyzing safety data to ensure the safety of pharmaceutical products, including post-marketing and investigational compounds.
You will work closely with cross-functional teams to ensure compliance with regulatory requirements and company policies, leading initiatives to automate and digitalize pharmacovigilance processes to improve efficiency and accuracy.
- Oversight of adverse event data collection, processing, and reporting
- Ensuring regulatory compliance for safety reporting
- Development and maintenance of standard operating procedures (SOPs) related to safety data management
- Cross-functional team collaboration for safety surveillance activities
- Line listing and summary tabulation preparation for periodic safety reports (PBRERs, DSURs, PADERs)
Required Skills and Qualifications:
- Bachelor's degree in Life or Computer Science; Master's degree in Data Science preferred
- Minimum 5 years of experience in pharmacovigilance, drug safety, or a related field
- Experience with pharmacovigilance databases and safety management systems
- Regulatory inspection and audit experience
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
Benefits: Competitive benefits package, including Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance, and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection.
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