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Manager, Safety Data Analytics - Mumbai/Bangalore/Hyderabad

  • Job
    Full-time
    Senior Level
  • Data
  • Mumbai

AI generated summary

  • You need a bachelor's in a related field, 8+ years in pharma/pharmacovigilance, SQL proficiency, strong project management, and excellent analytical and communication skills.
  • You will manage a data analysis team, oversee daily operations, track performance metrics, support stakeholders, ensure data integrity, and lead cross-functional meetings while optimizing report generation.

Requirements

  • Bachelor's degree in computer science, data science, life science, or related discipline
  • Previous pharmaceutical industry experience, specifically experience in pharmacovigilance typically demonstrated by a minimum of 8 years of pharmaceutical experience.
  • Previous experience in management role preferred.
  • Experience with managing relationships with business partners and vendors.
  • Strong working knowledge of relational databases required.
  • Advanced knowledge of computer programming, specifically SQL.
  • Strong understanding of Pharmacovigilance regulatory framework, e.g., GxP, ICH
  • Strong understanding of Adverse Event processing
  • Working knowledge of Pharmacovigilance systems and understanding of processes supported required.
  • Strong project management and time management skills required.
  • Demonstrated ability to streamline workflow activities, evaluate processes and work in an agile environment to improve efficiency, quality and compliance is required.
  • Excellent computer proficiency, e.g., MS Office
  • Strong verbal and written communication skills required.
  • Strong presentation skills to fit target audience and key stakeholders required (including senior leaders).
  • Ability to influence without authority is required.
  • Ability to work independently to investigate and resolve technical or data issues with attention to detail is required.
  • Experience in hiring, retaining professional staff preferred.
  • Strong analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
  • Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude and strategic focus.
  • Demonstrated experience leading projects preferred.

Responsibilities

  • The Manager, Safety Data Analytics (SDA) is responsible for managing data analysis team within the global SDA group to ensure that requests for safety data are processed accurately and efficiently in compliance with our written guidelines and procedures, and meeting quality and timeliness standards.
  • The Manager, SDA is responsible for development and support of relevant processes and methodologies, ensuring they are adopted supporting timely report generation, maintenance of data integrity and compliance.
  • Define, track, and analyze performance metrics of their data analysis team that demonstrate adherence to quality and timeliness standards, and relevance of support provided to internal and external stakeholders.
  • Oversee daily operational activities within the SDA group, including tracking of requests.
  • Monitor and assess workload distribution.
  • Partner with stakeholders to provide SDA coverage during IST hours, ensuring efficient collaboration, problem-solving, and decision-making across the global team.
  • Provide support for Sr. Analyst/Scientist when engaging with requester and external SMEs to define requirements and strategy, as required.
  • Provide support for project-related work.
  • Provide continuity of coverage in support of QPPV.
  • Represent SDA in cross-functional meetings as needed.
  • Participate in recruitment of staff.
  • Develop and manage PV Reports report generation performance metrics, overseeing optimization of report generation times, monitoring scheduled report generations and, identifying trends and solutions for improvement with escalation as appropriate.
  • Develop and execute complex database searches.
  • Collect and confirm request requirements working closely with internal and external stakeholders to confirm report parameters.
  • Support operational projects impacting GSDR and downstream integrations.
  • Ensure appropriate escalation of issues to the leadership team.
  • Contribute to for the development and implementation of team control documents.
  • Support CAPA/QI resolution process for SDA, ensuring deliverables are met.
  • Interface with internal and external stakeholders on SDA deliverables.
  • Provide end of line review and approval for Audit and Inspection requests.
  • Participate and Lead cross-functional meetings that require SDA representation.

FAQs

What is the primary responsibility of the Manager, Safety Data Analytics?

The primary responsibility of the Manager, Safety Data Analytics is to manage the data analysis team within the global SDA group, ensuring accurate and efficient processing of safety data requests in compliance with guidelines and timeliness standards.

What qualifications are required for this position?

A Bachelor's degree in computer science, data science, life science, or a related discipline is required, along with a minimum of 8 years of pharmaceutical experience, preferably within pharmacovigilance.

Is previous management experience necessary for this role?

Previous experience in a management role is preferred for this position.

What technical skills are essential for the Manager, Safety Data Analytics?

Strong working knowledge of relational databases, advanced SQL programming capabilities, and a solid understanding of the pharmacovigilance regulatory framework are essential for this role.

Will the manager oversee daily operational activities?

Yes, the manager will oversee daily operational activities within the SDA group, including tracking and assessing workload distribution.

What types of metrics will the manager be responsible for tracking?

The manager will define, track, and analyze performance metrics that demonstrate adherence to quality and timeliness standards for the data analysis team.

How does the role support stakeholders?

The manager partners with stakeholders to provide SDA coverage during IST hours, ensuring efficient collaboration and problem-solving across the global team.

Will this role involve participating in recruitment?

Yes, the manager will participate in the recruitment of staff for the SDA group.

What type of projects will the manager support?

The manager will support operational projects impacting GSDR and downstream integrations, along with project-related work as necessary.

Are strong communication skills needed for this position?

Yes, strong verbal and written communication skills are required, along with strong presentation skills tailored to key stakeholders.

What is the working environment like for this role?

The working environment requires the ability to work independently with minimum supervision, meet tight deadlines, and maintain a positive attitude and strategic focus.

Is experience in hiring and retaining professional staff preferred?

Yes, experience in hiring, retaining professional staff is preferred for this position.

What qualities are necessary for problem-solving in this role?

Strong analytical skills to identify gaps and root causes of issues, along with the ability to think outside the box in developing solutions, are necessary for effective problem-solving in this role.

Will the manager be participating in cross-functional meetings?

Yes, the manager will represent the SDA group in cross-functional meetings as needed.

Hospitals and Health Care

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Profound Change Requires Boldness. Johnson & Johnson is the largest and most diversified healthcare products company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.