Associate Director, Drug Safety Physician, Medical Review
Bengaluru, Karnataka Job ID R0186342 Category Drug Safety Subcategory Research & Development Business Unit Research & Development Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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 product across all therapeutic areas. They are responsible for performing high quality medical assessment of individual case safety reports in the Global Safety Database to ensure compliance with domestic and international regulations, and ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to queries
Primary duties and responsibilities of the role include the following:
- 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 harmonization 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 the queries
- Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products
- Ensure compliance, consistency and timely medical review
- Ensures complete and timely medical review to ensure accurate and compliant reporting of ICSRs to regulatory authorities globally within regulatory time frames.
- Partners 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
Education and Competencies:
- Medical degree required or internationally recognized equivalent.
- USMLE/ECFMG/COMLEX-USA/FLEX preferred but not required.
- Minimum 5 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 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.
- Multi-tasking with the ability to successfully manage multiple critical issues simultaneously
- Demonstrate integrity
- Work productively in a high pressure environment
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Good analytical/judgment/ critical thinking capabilities to understand/analyze/synthesize and communicate
- Attention to details, computer literacy, knowledge of safety database
- Supports management to address operational issues or identify opportunities for improvements
- Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills
