Job Description

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, India
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Job Title - Manager, PV Safety System
Essential Job Duties and Responsibilities
This role serves as the key business liaison between Global Medical Safety (GMS) and Information Technology (IT) to ensure the smooth operation and operational planning of Pharmacovigilance (PV) Systems. Responsibilities include business ownership of PV Systems, overseeing daily operations, managing corrective and preventive actions (CAPAs), and maintaining data accuracy and integrity within PV systems.
The position requires extensive knowledge of evolving global PV regulations and the ability to assess their impact on processes, systems, and data management. This role is also responsible for identifying and implementing innovative solutions that improve compliance, efficiency, and quality across PV processes, systems, and interfaces.
Operational Management:

• Coordinate with stakeholders to ensure efficient day-to-day operations of PV Systems, in alignment with global business requirements.
• Coordinate the resolution of any operational issues or system defects that arise after system releases or upgrades. Work closely with IT and business units to track and resolve any deviations, ensuring minimal disruption to PV processes and ongoing system functionality.
• Execute post-go-live monitoring plans to ensure that all system deployments are functioning as expected. Identify any performance gaps or system deficiencies and escalate these issues as needed.
• Ensure adherence to PV systems data standards, promoting data accuracy, consistency, and compliance across all systems and processes.
• Manage the integrity of the data within the safety database, including managing database transfers into the safety database
• Manage operational projects impacting the safety systems and associated processes

Systems Compliance:

• Lead investigations into any late safety case reports, identifying root causes, and implementing corrective actions to prevent future occurrences.
• Collaborate with IT and cross-functional teams to ensure timely and effective closure of CAPAs, maintaining adherence to timelines and standards.
• Maintain an inventory of all PV systems aligned with the Pharmacovigilance Systems Master File.

• Communicate PV system releases/ upgrades and compliance and performance metrics to the appropriate groups.
• Participate in PV Audits and Inspections

Business Ownership:

• Support the maintenance of GxP/GMP compliance for PV systems, ensuring day-to-day operational adherence to global industry regulations under the guidance of senior leadership.
• Coordinate the resolution of post-release system issues ensuring timely escalation and resolution in line with business priorities.
• Assess the impact of emerging global regulations on PV systems, data integrity, and operational standards. Recommend remedial actions to maintain compliance and data quality.

Innovation:

• Work with IT and cross-functional teams to implement innovative solutions in alignment with strategic goals set by leadership.

Training and Development:

• Maintain knowledge of department policies and procedures

• Complete development activities as applicable
• Maintain 100% compliance in all assigned training activities
• Maintain industry and regulatory knowledge

Other requirements:

• Perform additional duties as required to support business needs, including special projects, cross-functional initiatives, and emerging priorities
• Maintains compliance with company guidelines and HR policies.

Minimum Qualification
Education:

• BA or BSc degree in either an IT related field or health related field or other related scientific degree/qualification

Industry & Project experience:

• Previous industry and/or clinical experience with a focus on pharmaceutical safety related areas, including individual and aggregate reports, demonstrated by a minimum of 5 to 7+ years experience
• Knowledge and experience with single case safety reporting processes and regulatory compliance, and experience of international safety reporting /regulations

Management/Leadership experience:

• Ability to lead cross-functional groups.
• Ability to coordinate across multiple centers
• Ability to utilize appropriate initiative and autonomy in achieving objectives; works independently

Change Management:

• Ability to lead change
• Ability to thrive in a global matrix environment
• Demonstrates strong Credo values

Other skills:

• Excellent verbal, written and presentation skills
• Excellent computer skills (e.g. standard MS Office tools)
• Strong understanding of IT systems that support the entire PV process
• Teamwork and collaboration

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