Johnson & Johnson looking for Area Safety Head

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Post : Area Safety Head India, Local Safety (New Consumer Health Company)

Job Description:
As the Area Safety Head, India, Local Safety (New Consumer Health Company) you will be responsible for ensuring that the Local Operating Company (LOC) safety activities for the area (India and South Asia) related to all products, are managed in compliance with local regulations and company policies/procedures at a local, regional, and global level and in accordance with any product vigilance agreements with third-party business partners. You will also act as the Local Operating Company (LOC)’s and assigned territories’ (as applicable) main contact point for pharmacovigilance matters with the local Health Authority. You will be responsible for having appropriate product vigilance and risk management systems in place in order to assure appropriate oversight for products within its responsibility.

Roles and Responsibilities :
• Providing Line-Management and/or oversight (vendor resource) in the area collaborative network.
• Maintaining up-to-date knowledge of local requirements for pharmacovigilance, including reporting requirements (for all applicable product classes in the territory)
• Collaborating with the global team to implement process changes required in the identification of new requirements
• Maintaining oversight on day-to-day adverse event inbound and outbound reporting as applicable in the given territory
• Receiving and supporting the responses to safety-related Health Authority queries in the territory
• Collaborating with global and local teams to notify local Health Authorities of any safety issues including SSI/ESI and signals
• Providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master File
• Collaborating with the global team to meet requirements for local PSMF if applicable
• Collaborating with local and global teams to ensure pharmacovigilance compliance with local company-sponsored programs and research activities
• Ensuring the provision of information to global teams for local activities compliance with individual cases and periodic safety reporting

• Implementing risk management plans
• Key performance indicators related to overseeing the local implementation of any other specific risk management activities
• Supporting local Health Authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable
• Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances and develop and implement effective CAPA (Corrective and Preventative Action)
• Maintaining local procedures where applicable and assessing the impact of changes to global procedures on local procedures
• Ensuring current knowledge of all relevant company procedures
• Training and ensuring document management and archiving

Candidate Profile
• 6-8 years of relevant experience
• Pharmaceutical industry experience including product vigilance responsibility role
• Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field
• Proven ability to organize workflow activities and manage multiple critical issues
• Experience with vendor resource oversight
• Awareness and familiarity with industry principles of product vigilance, drug development, and pharmacology
• Expert knowledge of Global, Regional, and Local Procedural Documents as applicable
• Computer literate with knowledge of relevant IT safety systems
• Excellent verbal and written communication skills
• Proven ability to negotiate and communicate with internal and external customers
• Ability to establish and maintain open relationships within the organization and with authorities
• Demonstrable knowledge of all local requirements and global aspects of product safety
• Fluency in the national language(s) and the English language

Additional Information
Experience : 6-8 years
Location : Greater Mumbai
Industry Type : Pharma / Healthcare
Functional Area : R&D
End Date : 30th September, 2022