Scientist Pharmacovigilance Single Case Processing

3 weeks ago

Hyderabad, India Haleon Full time

**Job Description**:
**Site Name**: India - Andra Pradesh - Hyderabad

**Posted Date**: Mar 2 2023

Hello. We’re **Haleon.** A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

**Job Purpose**:
The Scientist Pharmacovigilance Single Case Processing, Operational Excellence (OPEX), position will be responsible for supporting the safety of all Haleon (HLN) consumer, patients & clinical trial participants administered or using Haleon products, by supporting the successful collection, processing and reporting of safety data globally.

Specifically, the Scientist PV SCP, OPEX will support the implementation of novel approaches for Pharmacovigilance single case processing, data collection and extraction in order to meet regulatory compliance worldwide.

The job holder will support the global organization to drive the delivery of Pharmacovigilance case management activities with high quality and compliance. The job holder will ensure quality controls and quality assurance for the business. The position reports into the global Consumer Safety Operations and Regions (CSOR) Single Case Processing team.

The job holder will sit on the Haleon global safety database development team, while ensuring global case management activities align with HLN standards for processing of human safety information (HSI) and that regulatory requirements for case processing, including quality, on-time reporting to authorities and partners worldwide is achieved. This is done by serving as SME for safety database development and migration (DITL testing, validation, etc.) and working collaboratively with suppliers and vendors under strict program timelines. This individual will also provision quality and control metrics for the business.

The job holder provides relevant recommendations and concept proposals to the Associate Director of Pharmacovigilance OPEX and develops operative compliance processes to ensure the understanding and implementation of case management requirements across the PV business units within Haleon.

**Key Responsibilities**:

- Serve a Haleon PV Ops, Single Case Processing global safety database SME contributing to the development, implementation, launch and maintenance of the global safety database with critical attention to the program's success, while ensuring global case management activities align with HLN standards for PV processing.
- Support tracking of PV SCP QA/QC KPIs, CAPA and regulatory enquiries sent to CSOR SCP, ensuring appropriate, thorough and timely responses and archiving, ensuring the successful retrieval of documentation and supporting inspection-readiness.
- Where process or training issues are identified, facilitates investigation into root cause, creation of corrective/preventative actions (CAPAs), and supports with remediation of process/training needs.
- Support on impact assessment for regulation changes that may impact CSOR activities, assesses impact, coordinates implementation of changes and tracks change.
- Generates new ideas and proposals for global implementation; contributes to advancement of CSOR methodology and optimization of processes.
- Manages CSOR Excellence mailboxes for responsible workstream and responds to allocated queries in a timely and professional manner.
- Where quality, compliance or other issues are identified, supports with recommendations and escalates to CSOR management/ Associate Director, as appropriate.
- Support Haleon during Health Authority interactions on Single Case Processing, OPEX in case of an inspection or partner audit.

**_ Why You?_**:
**Basic Qualifications**:

- Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Toxicology, Medical Engineering) with commensurate experience.
- Position requires practically-applied demonstration of intellect plus an applied level with experience in the pharmaceutical industry in pharmacovigilance, regulatory affairs or other related industry discipline.
- Bachelor’s degree in a scientific or medically related field, plus **8-10 years of experience in the pharmaceutical industry in pharmacovigilance**, regulatory affairs or other related industry discipline or combined.

**Other Job-Related Skills/Background**
- Good knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, clinical safety documentation, reporting of adverse events from clinical trials and spontaneous sources, local regulatory requirements, and pharmac

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