Manager- Pharmacovigilance at Medreich Limited -R

Manager- Pharmacovigilance at Medreich Limited
Medreich Limited - Bangalore, Karnataka

To provide proactive safety surveillance across the lifecycle of Medreich products, and Support development and execution of risk management plans, risk assessment, and risk communications while complying with legal/regulatory requirements concerning adverse event monitoring and reporting. To make sure that Adverse Event reports are processed in an accurate and timely fashion in accordance with regulatory requirements. Handling medical information enquiries from both in-house and external customers, and management of Frequently Asked Questions To be in charge of processing of incoming adverse event reports and reporting to regulatory authorities, with the objective of achieving a high level of regulatory compliance. To make sure that that all Pharmacovigilance activities are conducted in accordance with SOPs, Medreich Work Instructions, Good Clinical Practice guidelines and regulatory requirements. Preparation and upkeep of Pharmacovigilance documentation and SOPs. Coordinate for any internal audits or external inspections in different locations To coordinate for Periodic Safety Update Reports. To liaise with Clinical Research personnel in the preparation of safety data required in support of the clinical research programme. Conduct safety data analysis in support of developing and updating safety sections of regulatory documents, informed consent, annual reports, company core data sheets, product labels, etc. To respond to all medical and technical enquiries accurately and in accordance with current opinion/knowledge, the published literature and Medreich in-house expertise. To develop a database of frequently asked Questions, Contact with all members of the internal teams including Regulatory Affairs, Quality Control, Quality Assurance, and Sales & Marketing Etc. Outstanding interpersonal skills in developing effective relationships with safety data customers and colleagues, with the ability to communicate with diverse individuals and groups Proficiency in the processing, assessment of safety data Demonstrated computer literacy, with proficiency in the used and management of safety Databases, Window, Excel, etc. Previous experience with adverse event reporting systems, EU /UK drug safety/Pharmacovigilance requirements