Job Description

Description: Senior Safety Specialist - Local Drug Safety

Mumbai

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.

Janssen Research & Development area develops treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. The Principal Scientist Technical Integrator is the DPD (Drug Product Development) representative and single point of contact on the CMC new product development teams.

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Johnson and Johnson India is recruiting Senior Safety Specialist- Local Drug Safety for Mumbai location.

This position is an important one and will play a key role in ensuring Pharmacovigilance system in South Asia to fulfil the responsibility for the coordination and execution of all Pharmacovigilance (PV) activities in the pharmaceutical sector and bringing value to the patients using our products.

- Oversight of the PV System & Overall responsibilities

- Act as Local Nominated Person (including back-up nominated person)

- Collaborate with Case Management team in planning and ensuring timely submission of Aggregate Reports according to local regulations.

- Establish adequate collaboration with the Case Management team to provide local data as required to support the preparation of Aggregate Safety Summary reports (PBRER/PSUR, DSUR, etc.), undertake local review and submission of PBRERs/PSURs, provide due dates to GMS and promote synchronization with the Global PSUR schedule, in accordance with local regulatory requirements.

- Oversight of data generating activities to ensure appropriate review and reporting process are included in project documents for reporting potential AEs (e.g., patient support programs, market research surveys, internet sites), as applicable.

- Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical Affairs and Marketing organization in collaboration with the International Medical Safety leader.

- Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate.

- Provide Risk Management Plan (RMP) status updates.

- Prepare local RMPs/Addendums, etc. as applicable.

- Ensure implementation of Global Pharma and Consumer Cross-Pharma PV relevant Procedural Documents as applicable and/or write, validate and implement the Local Implementation Documents (LID) for Regional / IPV Standard Operating Procedures (SOPs)/Working Practices and verify adherence. Where appropriate develop local controlled procedures to cover local aspects of PV activities.

- Management of local PVAs and ensure local implementation, including LSU training and adherence to PVAs.

- Function as IPV Lead reviewer, to have PVA implementation and oversight

- Focused engagement in local industry associations and drive local policy shaping initiatives based on One J&J Voice. Act as the local PV contact person for all PV audits and inspection and coordinate the audit and inspection preparations for internal PV audits (e.g., Bioresearch, Quality & Compliance (BRQC)) and external PV inspections.

- Assist inspectors/auditors, support document requests in collaboration with relevant stakeholders.

- Address follow-up actions from findings.

- Ensure that a process is in place for reporting of AEs after hours, and testing is documented as per Global and Regional requirements. Education:

Medical Officer or Pharmacist:

Experience and Skills:

- 4-5 years relevant experience in Pharmacovigilance, Regulatory Affairs.

- Knowledge about PV Global and local regulations

- SDEA, Audit and Inspection management

- Knowledge about end to end Pharmacovigilance processes

Other:

At this time no travel is needed

Are you ready to impact the world?

Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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