Require Scientific Manager in Pharmacovigilance & Medical Affairs at Himalaya Drug Company
The Himalaya Drug Company was founded in 1930 by Mr. M. Manal with a clear vision to bring Ayurveda to society in a contemporary form and to unravel the mystery behind the 5,000 year old system of medicine. This included referring to ancient ayurvedic texts, selecting indigenous herbs and subjecting the formulations to modern pharmacological, toxicological and safety tests to create new drugs and therapies.
Post : Scientific Manager (Pharmacovigilance & Medical Affairs)
- To develop the system, process and modus operandi of Global Pharmacovigilance Cell for Unified Pharmacovigilance System at Himalaya, to have a robust, well structured, process driven PV system across regions (global level).
- Pharmacovigilance Coordinator for Global Pharmacovigilance Cell to coordinate with respective HUB across globe.
- To develop the procedures, SOPs, guidelines and other standard materials required for PV compliance in accordance with applicable regulatory guideline of the various geography.
- Evaluates & assess the drug safety software tool in collaboration with IT team to organize and process the PV system to cater the global need of Himalaya. Coordination for safety related activities with 24/7 medical & safety cell of the organization.
- SAE management optimization, Pharmacovigilance operations management, review of performance of existing drug safety activities. Organize and ensure timely reporting of SAEs. Write and/ or review SAE narratives and CIOMS Forms for the reported events.
- Directs and oversees activities for a project which may include but is not limited to individual case safety reports, aggregate reporting, medical information response fulfilment, risk management plans.
- Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
- Assess Lifecycle Safety data report to relevant authorities in a format compatible to requirement.
- Oversee the activities of team related to safety aspect of all the Himalaya products and Imparts/ arrange safety trainings to study team & marketing team. Manage safety analyses and signal detection activities and contribute to the Reference Safety
- Information and Safety Communications.
- Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event reports received for Himalaya products.
- Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related safety issues.
- Serving as a link between company and the patients or healthcare experts to provide scientific validated information on product safety.
- Develops the Safety Management Plan for the new clinical studies.
- Contribute and provide review on safety sections for protocols other clinical trial related documents.
- Supports the Clinical Operations teams with respect to safety related issues as required and oversees reconciliation of clinical and safety databases.
- Management of Pharmacovigilance System Master File (PSMF).
- Assist audits/inspections of systems and procedures to ensure quality, integrity and compliance with pharmacovigilance and safety reporting. Response to regulatory findings relevant to safety operations and processes.
- Support in medical affairs activities related to Himalaya products.
- Provide support to marketing team for responding scientifically to the medical queries raised by the Doctors/ Field staff.
Degree in modern medicine (MBBS) and/ or MD with approximate 2-3 years of experience in Pharmacovigilance is must for the position.
Experience : 2-3 years
Qualification : MBBS or MD
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance & Medical Affairs
End Date : 5th February, 2019
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