Life Science Job at Johnson & Johnson Jobs Mumbai
Looking for a rewarding Life Science Job with a global healthcare leader? Johnson & Johnson is inviting applications for the position of Specialist Local Medical Safety India in Mumbai. This exciting opportunity is ideal for professionals with expertise in pharmacovigilance, drug safety, regulatory compliance, and healthcare research. If you are passionate about patient safety and aspire to build successful Life Science Careers, this role offers an exceptional platform to work with one of the world’s most respected healthcare organizations while gaining exposure to global safety systems and regulatory frameworks.
About Johnson & Johnson
Johnson & Johnson is one of the world’s leading healthcare companies dedicated to improving human health through innovation in pharmaceuticals, medical devices, and healthcare solutions. With a strong commitment to patient well-being, scientific advancement, and ethical business practices, the company continues to develop innovative treatments that address some of the world’s most pressing healthcare challenges.
Operating across multiple countries, Johnson & Johnson provides employees with opportunities to contribute to meaningful healthcare innovations while building successful and rewarding Life Science Careers.
Job Details:
- Job Title: Specialist Local Medical Safety India
- Function: Product Safety
- Sub Function: Pharmacovigilance
- Category: Scientist, Pharmacovigilance (ST4 – E24)
- Location: Mumbai, India
- Work Pattern: Hybrid Work
- Requisition Number: R-080776
At Johnson & Johnson, health is at the center of everything. Through healthcare innovation, the organization strives to create a world where complex diseases are prevented, treated, and cured; where treatments are smarter and less invasive; and where solutions are personalized. Through expertise in Innovative Medicine and MedTech, Johnson & Johnson is uniquely positioned to innovate across the full spectrum of healthcare solutions to deliver breakthroughs that impact health for humanity.
Guided by Our Credo, Johnson & Johnson is committed to creating an inclusive work environment where every employee is respected as an individual. The company values diversity, dignity, merit, and equal opportunities for all employees.
Position Overview
The Specialist Local Medical Safety India will be part of the Johnson & Johnson Innovative Medicine Office of the Chief Medical Officer (JJIM OCMO). This Life Science Job is responsible for ensuring that local Pharmacovigilance (PV) systems are managed in compliance with local regulations and company policies while supporting safety monitoring, regulatory compliance, risk management, and local benefit-risk activities.
Key Responsibilities
General Job Duties and Responsibilities
- Ensure that the local Pharmacovigilance (PV) system is managed in compliance with local regulations and company policies/procedures at local, regional, and global levels, including adherence to PV agreements with third-party business partners.
- Ensure compliance with assigned training curriculum.
- Serve as an ambassador of the Local Medical Safety mission and vision.
- Participate in or lead Local Medical Safety (LMS) projects and initiatives at local, regional, or global levels.
ICSR Management and Oversight
- Ensure local collection, review, reporting, reconciliation, and follow-up of Individual Case Safety Reports (ICSRs).
- Manage and maintain active involvement in day-to-day ICSR management activities, as applicable.
- Ensure implementation of local literature monitoring processes.
- Maintain oversight of corresponding vendor activities as required.
Compliance Activities
- Ensure PV audit and inspection readiness at the local operating company (LOC) level.
- Maintain oversight of ICSR inbound and outbound compliance.
- Collaborate with Medical Safety Quality (MSQ) to perform ICSR reconciliations and review compliance dashboards for accuracy.
- Increase Pharmacovigilance compliance awareness and business relevance among stakeholders.
- Ensure ownership of PV-related findings and Corrective and Preventive Actions (CAPAs).
- Escalate compliance issues in a timely manner to the Country/Cluster Safety Head (CSH).
- Address follow-up actions from Local Safety Unit (LSU)-owned non-conformances, including LSU-related CAPAs.
Aggregate Reporting
- Review, translate (where applicable), prepare, submit, and track aggregate reports as required by local regulations.
- Ensure aggregate reporting compliance requirements are met.
- Support preparation of aggregate reports and communicate due dates to Global Medical Safety (GMS).
- Promote synchronization with the global aggregate reporting schedule in accordance with local regulatory requirements.
- Collaborate with local Regulatory Affairs teams to support reporting activities.
Local Regulatory Requirements
- Monitor new and updated local PV regulations and evaluate their impact on local and global processes.
- Notify relevant local, regional, and global stakeholders of regulatory changes.
- Perform procedural document impact assessments.
- Support implementation of Global PV procedural documents.
- Implement new or updated PV regulations as required.
- Provide input into LMS-wide processes, systems, and policy development.
- Participate in local industry associations and contribute to policy-shaping initiatives using a One J&J Voice approach.
Pharmacovigilance Service Provision
- Ensure satisfactory execution of daily PV and safety activities for medicinal and non-medicinal products, including medical devices.
- Collaborate with local Marketing Authorization Holders (MAHs) to meet regulatory responsibilities and business objectives.
- Manage and implement local Pharmacovigilance Agreements (PVAs).
- Support inclusion of appropriate PV language in vendor contracts.
- Provide timely and accurate EU Pharmacovigilance System Master File (PSMF) contributions.
- Establish and maintain local PSMF processes where applicable.
- Ensure proper handling of Health Authority (HA) safety-related queries, including communication, response, and escalation.
- Communicate with Health Authorities when necessary to support policy harmonization and process improvements.
- Ensure business continuity to safeguard compliance.
- Support Related Research Activities Center of Excellence (RRA CoE) for local Related Research Activities (RRA).
- Collaborate with project owners and LMS operations regarding adverse event reporting within local data-generating activities.
Local Benefit-Risk Activities
- Medical Insights
- Develop product knowledge with emphasis on safety profiles, therapeutic areas, and disease pathways.
- Support the needs of local Medical and Commercial organizations in collaboration with Risk Management Leads and LMS product teams.
- Participate in therapeutic area and product-focused cross-functional teams.
- Provide safety expertise during team discussions.
- Communicate relevant safety information to local stakeholders.
- Deliver training on safety-related topics where appropriate.
- Participate in LMS product teams as applicable.
Local Product Compliance Activities
- Conduct local product compliance activities in collaboration with stakeholders such as Medical Safety Officers (MSOs).
- Communicate new safety information promptly to Global Medical Safety and local stakeholders.
- Participate in local safety signal detection activities where applicable.
- Support discussions related to Risk Management Plans (RMPs) and associated addendums.
- Participate in local implementation of risk minimization activities.
- Engage with Health Authorities regarding RMP requirements.
- Prepare local RMPs and addendums in accordance with local and global procedures.
- Support implementation of Company Core Data Sheet (CCDS) updates into local labeling documents, including Summary of Product Characteristics (SmPC) and Patient Leaflets.
Training Responsibilities
- Support global rollout of Adverse Event/Product Quality Complaint (AE/PQC) training programs.
- Provide safety training to maintain awareness of safety reporting requirements.
- Manage AE/PQC training for distributors and vendors.
- Coordinate translation of training materials where required.
Qualifications
Minimum Qualifications
- Degree in Life Sciences, Health Sciences, or Pharmaceutical Sciences preferred.
- Proficiency in medical terminology.
- Excellent verbal and written communication skills.
- Fluency in English and the national language(s).
- Ability to communicate and negotiate effectively with internal and external stakeholders.
- Ability to establish and maintain relationships across the organization and with regulatory authorities.
- Strong analytical skills with the ability to identify gaps, determine root causes, and develop solutions.
- Excellent computer proficiency, including Microsoft Office applications.
- Proficiency in global and local Standard Operating Procedures (SOPs).
- Ability to work independently with minimal supervision while managing tight deadlines.
- People leadership experience preferred for people manager responsibilities.
Experience For Life Science Job
- Preferably a minimum of 2+ years of pharmaceutical industry experience.
- At least 1 year of experience in a product vigilance or pharmacovigilance role.
Required Skills
- Analytical Reasoning
- Clinical Operations
- Collaboration
- Cross-Functional Collaboration
- Detail-Oriented Approach
- Execution Focus
- Pharmacovigilance
- Quality Control (QC)
- Quality Management Systems (QMS)
- Regulatory Affairs Management
- Report Writing
- Root Cause Analysis (RCA)
- Safety Investigations
- Safety-Oriented Mindset
- Serious Adverse Event Reporting
- Technological Proficiency
