Senior Safety Analyst - Mumbai/Bangalore/Hyderabad

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Product Safety

Job Sub Function:
Drug & Product Safety Operations

Job Category:
Professional

All Job Posting Locations:
Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, Maharashtra, India

Job Description:

The Safety Data Analytics (SDA) Sr.

Analyst will bring experience in data retrieval, and report development strategy.

This individual, will manage, coordinate, and fulfil various sophisticated requests, collaborating with programmers on investigations and query builds supporting health authority, QPPV, inspections, audits, legal, ad hoc requests, etc.

They will transcribe business requests into technical requirements, confirming safety data output is fit for purpose, and is aligned with team guidelines and procedures ensuring data standards are met.

They will provide support and maintain close collaboration with cross-functional safety partners, to ensure requested results are delivered in accordance with developed standards and customer expectations.

Moreover, they will actively participate in cross-functional projects and opportunities, on behalf of the SDA team.

 

The SDA Sr.

Analyst will have advanced relational database, Pharmacovigilance systems and processes knowledge, including understanding of GxP.

Operating with a high level of independence, they will consistently deliver high-quality results.

Principal responsibilities include:


* Support Daily Operations: Assist in executing daily operational activities within the SDA group to enhance efficiency and effectiveness.


* Customer Collaboration: Work closely with stakeholders, ensuring seamless communication and operational support.


* Stakeholder Communication: Communicate effectively with stakeholders regarding data quality expectations and findings to foster accountability and trust.


* Continuity of Coverage: Contribute to the maintenance of coverage for QPPV requirements to acquire data from the Global Safety Database at any given time.


* Facilitate Team Collaboration: Promote a collaborative environment that encourages problem-solving and effective decision-making across the global team.


* Report Investigations: Support the investigation of Pharmacovigilance (PV) reports, collaborating with SDA programmers, IT, vendors, and other stakeholders.


* Training and Mentorship: Provide guidance and support to team members on best practices for maintaining high-quality data standards....