Medical Reviewer Job at Takeda
A rare chance has emerged for qualified candidates to apply for the medical reviewer job at Takeda in Bengaluru, Karnataka. This role offers an opportunity to contribute significantly to global pharmacovigilance and medical assessment processes.
About Takeda:
Takeda is a global, research and development-driven pharmaceutical company headquartered in Japan, dedicated to bringing better health and a brighter future to patients worldwide. The organisation focuses on developing innovative medicines and therapies across various therapeutic areas, including oncology, gastroenterology, and neuroscience. The medical reviewer job plays a crucial role in ensuring the safety and efficacy of Takeda’s products, aligning with the company’s commitment to patient safety and regulatory compliance.
Job Details:
- Job Name: Associate Director, Drug Safety Physician, Medical Review
- Job ID: R0186342
- Category: Drug Safety
- Subcategory: Research & Development
- Job Type: Full-time
Job Description:
The Associate Director, Medical Review supports Global Pharmacovigilance with an emphasis on overseeing medical assessment of individual case safety reports from investigational and marketed products across all therapeutic areas. They are responsible for performing high-quality medical assessments of individual case safety reports in the Global Safety Database to ensure compliance with domestic and international regulations and effective communication with both internal and external stakeholders on individual case safety assessment-related issues and prompt responses to queries.
Key Responsibilities:
- Perform and conduct oversight of global medical review of individual case safety reports for Takeda investigational and marketed products from all sources, including but not limited to the following:
- Seriousness criteria confirmation and expectedness/listedness assessment.
- Review of the reporter’s causality and company causality assessment.
- Event confirmation and coding as per convention.
- Analysis of similar events as required.
- Provide sound rationale in Company Comment regarding causality.
- Ensure due diligence in adequate follow-up and timeliness of expedited reports.
- Collaborate with other PSPV personnel from other functions (AE processors, safety scientists, and Global Safety Leads) in evaluating the safety profile of Takeda products.
- Establish with alliance partners harmonisation and industry-standard medical review and case assessment standards.
- Ensure effective communication with both internal and external stakeholders on individual case safety assessment-related issues and prompt response to queries.
- Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products.
- Ensure compliance, consistency, and timely medical review.
- Ensure complete and timely medical review to ensure accurate and compliant reporting of ICSRs to regulatory authorities globally within regulatory time frames.
- Partner with safety operations teams to ensure consistency of work practices and SOPs.
- Support inspections and audits, and Corrective and Preventive Actions (CAPA) related to medical review and case assessment.
- Support initiatives or projects improving Medical Review activities and processes.
- Mentor and train new and/or junior colleagues.
- Work with the Head of Medical Safety Review to implement and augment onboarding and training processes.
- Perform such other duties as requested by management.
Eligibility Criteria for this Medical Reviewer Job:
- Medical degree required or internationally recognised equivalent.
- USMLE/ECFMG/COMLEX-USA/FLEX preferred but not required.
- Minimum 7+ years pharmaceutical or health care-related industry experience.
- Minimum 3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine.
- Minimum 3 years of experience in pharmacovigilance, including medical review of individual case safety reports.
- Good working knowledge of US, EU, MHRA drug safety regulations, CIOMS, and ICH guidelines.
- Multitasking with the ability to successfully manage multiple critical issues simultaneously.
- Good analytical/judgment/critical thinking capabilities to understand/analyze/synthesize and communicate.
Required Skills for this Medical Reviewer Job:
- Attention to detail, computer literacy, knowledge of safety database.
- Proven ability to work in an international environment and with cross-functional teams.
- Strong interpersonal skills, assertiveness, team spirit, and coaching skills.
- Demonstrate integrity and work productively in a high-pressure environment.
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
