Boehringer Ingelheim Pharmacist Job Opening - Apply Online
"Unlock Your Dream Job in Mumbai: Local Patients Safety Executive Needed!"

Boehringer Ingelheim Pharmacist Job Opening – Apply Online

Boehringer Ingelheim Pharmacist Job Opening – Apply Online. Interested and eligible applicants can check out all of the details on the same below:

Local Patients Safety Executive – Mumbai

JOB ID – 16763

The Position

Team contribution to ensure the establishment and maintenance of a local pharmacovigilance (PV) system to support patients’ and clinical trial subjects’ 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 regarding 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 in
    formation in Global Safety Platform.
  • Provides high-quality translation of the case receiving in the local language or, in cases 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 documented in the 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 Ethics Committees/Institutional Review Board (IRB) is performed in line with BI processes and regulatory requirements.
  • Provide feedback to LPSL on any discovered findings regarding the enhancement of the 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 limited 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 the 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, contributing to the 24-hour availability.
    • Support of local inspections/audits and participation in PV audits and PV inspections as requested.
    • Maintaining 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 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 with 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 implementation activities to enhance PV compliance culture and PV awareness at the local level of the organization in line with global recommendations.
    • Support 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.

HR Direct contact information:

Our Company

At Boehringer Ingelheim, we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative, and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

Link to Original Notification to apply: Click here to apply

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