Lead- Medical assessment - Hyderabad @ Dr. Reddys

Lead- Medical assessment 1. Medical evaluation of individual adverse event case safety reports, including but not limited to all serious and expedited reports and all pregnancy reports
2. Accountable for review and interpretation, analysis and summarization of Accountable for review and interpretation, analysis and summarization of aggregate safety data from all sources including spontaneous, clinical, post-marketing and observational studies, literature review and product quality, (e.g. RMP, PSUR, ad-hoc regulatory reports, etc)
3. Provide therapeutic areapharmacovigilance issue guidance in the context of leadingmanaging a Pharmacovigilance Physician product team andor technical leadership in single case assessment
4. Working as medical professional expert for risk-benefit evaluations and responsible for medical evaluations for any applicable risk evaluation and mitigation obligation and guides risk management plans for both development and commercialized products. Defining of Medical review process under the supervision of the PV head and implementing the same.
5. Timely resolution remedial action of any CRO queries and help in smooth functioning of CROs.
6. Building relationships with internal and external key stakeholders.
7. Assessing existing processes vis- -vis external benchmarks and industry best practices
8. Identifying areas of improvement and propose recommendations in function council reviews; develop and implement action plan for approved changes
9. Lead or participate as members of pharmacovigilance matrix-teams responsible for pharmacovigilance activities focused on individual products and therapeutic areas.
10. Responsibilities include training activities, participation in selected reviews of aggregate reports such as PSURs, PADERS, contributing to the development and implementation of risk minimization action plans, etc Product information leaflet 1. Interact with regulatory team and check the status of DRL labeling documents

2. Do gap analysis of DRL labeling documents

3. Assess the vendor(s) on capabilities on labeling documents udpate and maintainance

4. Streamline the process of DRL labeling documents update and maintainance Medical affairs

  1. Provide medical inputs for product specific website development (example: Trastuzumab and Bevacizumab)

2. Provide or review of product specific safety information during website development (example: Trastuzumab and Bevacizumab)

3. Train the team on therapeutic areas and molecule specific as per the organization requirement (example: Rituximab and Bevacizumab)