Job Description

The PositionTeam contribution to ensure the establishment and maintenance of a local pharmacovigilance (PV) system to support patient's and clinical trial subject's safety and public health in India. Self-dependent execution of Individual Case Safety Report (ICSR) processing in high quality and in line with local regulatory requirements and BI internal processes. The Patient Safety & Pharmacovigilance Associate ensures that all delegated operative tasks of the local BI Pharmacovigilance System are prioritized, performed in a timely manner and are regularly checked according to the current BI processes. Close cooperation with BI-internal interfaces and proactive support of people contacting PV in India with regards to Pharmacovigilance related matters.Tasks & Responsibilities

• Self-dependent execution and team contribution for management of PV relevant information received locally (e.g., ICSR collection, local processing, follow-up, reconciliation, documentation, and archiving) including PV reporting to local Health Authorities/Ethics Committees in line with applicable regulations and respective BI processes.
• Intake, case classification and local review of Patient Safety relevant information in Global Safety Platform.
• Provides high quality translation of the case receiving in local language or in case with complex information (where feasible within the required timelines) coordinates the translation with the external vendor, where applicable.
• Ensures personal information is redacted from source data in line with data protection requirements.
• Queries concerning case information (=Follow up) are sent out within the valid BI timelines and properly document in Global Safety Platform.
• Queries are easy to understand for external customers and targeted to the missing information (e.g. by prepopulating forms / questionnaires with available information).
• ICSR Submission to local Health Authorities and /or the Ethic Committees/Institutional Review Board (IRB) is performed in line with BI processes and regulatory requirements.
• Provide feedback to LPSL any discovered findings on enhancement of ICSR processing process.
• Contributes to the quality of the local PV system by taking over and executing the following tasks in line with BI processes and timelines, for examples but not limit to:
• Reconciliations are performed with all concerned interfaces (e.g. Medical Affairs, Technical Product Complaint, Customer Service Center, Market Access, PV Vendors, License Partners).
• Support of Pharmacovigilance training including translation of global training material into local language
• Conduct website screening/tests of BI websites regarding the correct reporting of PV relevant information.
• Conduct CRM Screening for patient safety relevant information.
• Perform Out of Office (OoO) test calls by BI internal interfaces and external Vendors, which are contributing to the 24 hours availability.
• Support of local inspections/audits and participation in PV audits and PV inspections as requested.
• Maintaining of Local Tradenames (LTNs) and Preferred Product Descriptions (PPDs).
• Screens local scientific literature for identification of PV relevant information.
• Give support for local Pharmacovigilance Agreements (PVAs) with LPSL's guidance in cooperation with Global Partner Management
• Support of cross-functional colleagues in case of PV process related questions to IIS /NIS / local studies.
• All relevant documents are independently archived in a timely manner in accordance to Boehringer Ingelheim processes and regulatory requirements.
• External Archive: Archive retrieval checks are performed independently and timely and are documented.
• Support the implementation of RMP commitments in cooperation with the global PVWG and relevant local functions.
• Support the implementation activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations.
• Support of local inspection/audit readiness and participation in PV audits and PV inspections as requested.
• Support the LPSL by the set-up/optimizing of local PV processes including the takeover of subtasks e.g. creation/revision of the related documentation (Standard Operating Procedures (SOPs), Local PV System Framework, KMed Assets, etc.)
• Complete assigned Learning One Source (LOS) as per curricula on time.

Requirements

• Education: Health care professional e.g., physician, pharmacist or an appropriately qualified person with considerable Pharmacovigilance experience. Safety databases knowledge (ArisG/ LSMV mandatory).
• Sound knowledge of operative processing of PV-reports in the regulatory context.
• Good command of English in writing and speaking. Problem solving and multi-tasking skills.
• Ability to prioritize workload and perform under stress in situations in which working speed and sustained attention are critical aspects of the job.
• Result-oriented and ability to propose alternatives for process improvements.

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Boehringer Ingelheim