Associate Director, Drug Safety Physician, Medical Review

By 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 Takedas 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 Future Begins Here At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is Indias epicenter of Innovation, has been selected to be home to Takedas recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement. At Takedas ICC we Unite in Diversity Takeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team. 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 assessmentreview of the reporters causality and company causality assessmentevent 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 reportsCollaborate 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 standardsEnsure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to the queriesKeep management informed of special concerns and developing safety problems with investigational compounds and marketed productsEnsure compliance, consistency and timely medical reviewEnsures 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 assessmentSupport initiatives or projects improving Medical Review activities and processesMentor and train new and or junior colleaguesWork 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 7+ years pharmaceutical or health care related industry experienceMinimum 3 years clinical experience with patients following post-graduate training with significant knowledge of general medicineMinimum 3 years experience in Pharmacovigilance including medical review of individual case safety reportsGood working knowledge of US, EU, MHRA drug safety regulations, CIOMS and ICH guidelines.Multi-tasking with the ability to successfully manage multiple critical issues simultaneouslyDemonstrate integrityWork productively in a high pressure environmentAble to manage both time and priority constraints and to manage multiple priorities simultaneouslyGood analytical/judgment/ critical thinking capabilities to understand/analyze/synthesize and communicateAttention to details, computer literacy, knowledge of safety databaseSupports management to address operational issues or identify opportunities for .