HomeCustomer CentricPatient safety scientist (QC) | Astra Zenca Pharma | Chennai, India

Patient safety scientist (QC) | Astra Zenca Pharma | Chennai, India

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AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.

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You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.

Position: Patient Safety Scientist ( Quality Control )

Location: Chennai, Tamil Nadu, India

Job Description:

Purpose:

  • The purpose of the Patient Safety Scientist Quality Control (QC) Reviewer’s role is to support the Patient Safety team to produce documents of high quality.
  • The role manages and conducts QC activities to support the delivery of accurate, compliant, and submission-ready documents prepared by patient safety authors. Documents include (but are not limited to) PBRERs, FERs, SARs, ACOs, and regulatory responses.
  • To support on few Pharmacovigilance activities.

Primary Responsibilities:

  • This job description is intended to provide a general overview of the job requirements at the time it was prepared.
  • The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
  • Collaborate with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Responsibilities

1. Patient safety Document Support – Editing and Quality Review:

  • Ensure timely delivery of error-free, high-quality regulatory and publication documents that meet international standards of written English

  • Accurate errors in grammar, style, formatting, and syntax. Identify and fix flaws in logic and flow.

  • Verify uniformity and compliance of documents with internal and external standards (Follow AZ style and format).

  • Follow best-practice based on AZ standards.

  • Verify data against source files, ensure the accuracy and consistency of data and content within and between related documents.

  • General expectations

  • Maintain a strong customer focus.

  • Accountable for achieving timelines by managing activities efficiently and proactively.

  • Coach authors requiring development and take initiatives to improve writing skills

2. Pharmacovigilance activities:

  • Perform all Surveillance activities for established products with supervision.

  • Able to draft the periodic regulatory documents according to the agreed process and timelines for established products with supervision.

  • Support or draft production of high-quality and timely responses to safety queries with supervision.

  • Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals in partnership with the Safety Physician, for all products in the area of responsibility.

  • Support a performance-driven culture

  • Raises appropriate concerns/issues to senior staff in a timely manner.

  • Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures

  • Compliance with relevant procedural documents

  • Ensure good communication and guidance to AZ products

  • Liaise effectively and maintain excellent relationship with external contacts

3. Process efficiency and technology advancement

  • Maintain proficiency in applicable software, tools, processes, and workflows

  • Use creativity to introduce new tools, processes, and structure to accomplish broader organizational goals and meet standards while providing solutions to streamline team workflow (OPTIONAL)

  • Improve document processes by establishing uniform cross-organizational practices; suggest process or tool enhancements to improve effectiveness and minimize redundancy between databases and other tools (OPTIONAL)

4. Therapeutic & Disease State Management

  • Maintain a solid understanding of product and disease state information

  • Continue to develop therapeutic knowledge. Apply this knowledge in the activities listed above

Skills and Capabilities

High ethical standards, including a commitment to AstraZeneca values and behaviors

  • Strong written and verbal communication skills in English

  • Specialized knowledge of editing & proofreading techniques

  • Demonstrated ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues and external vendors

  • Demonstrated project management and time leadership skills

  • Cognitive abilities, including verbal reasoning, attention to detail, critical thinking, and analytical ability

  • Interpersonal skills and the ability to be flexible in varying environments

  • Ability to utilize high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates)

  • Ability to work well independently and as part of a team, within and across culturally and geographically diverse environments

  • Proven track record to assemble, share and apply key lessons across multiple projects

Other Information/Additional Preferences:

  • Preferred: Knowledge of medical and statistical terminology; willingness to expend effort in acquiring scientific knowledge and understand strategic issues

  • Preferred: General knowledge of scientific literature search and retrieval

Minimum Requirements –Education and Experience:

Qualification: Bachelor’s degree, preferably in life sciences. Advanced degree preferred

Experience: Total of 6 to 8 years of experience, Out of Which Up to 3 to 4 years of high-quality Medical Writing/Medical Content writing (with clear evidence of delivery) and quality review. Patient safety experience preferred

Last Date: 27th Dec 2020

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