Sr . Director Neptune Consultants - Navi Mumbai, .."R"

Sr . Director 
Neptune Consultants - Navi Mumbai, Maharashtra

Accountable for the local implementation and compliance of global Pharmacovigilance processes as described in respective SOPs and other relevant procedures. Responsible to issue local operating and working procedures for the fulfilment of global and national Pharmacovigilance requirements. Ensure that the personnel of the countries under scope (India, Nepal, Srilanka and Bangladesh) directly involved in the processing of safety information are  adequately trained. Diligently inform/escalate any emerging safety issue, changing regulations related to Drug Safety and other relevant topics, including any safety related questions or requests from Health Authorities, Ethics Committees or other formal bodies. Foster local cross-functional interfaces dealing with drug safety matters, e.g. Regulatory Affairs activities, PTC handling, websites sponsored by the company, Medical Information databases, interventional and non-interventional studies as well as other study-like activities, such as Patient Support Programs, Market Research and Active Online Listening Lead in Audit and Inspection preparation Responsible for writing submission of PSURs for domestic products Responsible for LQSD (local quality system documents) Managing PV resource and budgets Promoting PV values within company and building network with external stakeholders Support in RD Medical presentation during product launch Due diligence for new products (regulatory/ benefit to risk assessment) Post-Authorization Safety Studies (Drafting protocols, SAE management) Regulatory support for Branded Generics Implementation of Risk Management Plan Preparation of Package Inserts Line ManagementCLICK HERE TO VIEW/ APPLY