Experienced Specialist Local Medical Safety India - Mumbai

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We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Product Safety

Job Sub Function:
Pharmacovigilance

Job Category:
Scientific/Technology

All Job Posting Locations:
Mumbai, India

Job Description:

Experienced Specialist Local Medical Safety India - Mumbai

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

The employee is part of the Johnson & Johnson Innovative Medicine Office of the Chief Medical Officer (JJIM OCMO).

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 and in accordance with any PV agreements with third party business partners.



* Ensure compliance with own training curriculum.



* Be an ambassador of the Local Medical Safety mission and vision.



* Participate in or lead LMS projects and initiatives at local, regional or global level.



* The role holder will be expected to be based in the country/territory where they are responsible for Pharmacovigilance.



* Ensure support in having an appropriate system in place for Risk Management to assure oversight for products within its responsibility.



* Manage related local benefit risk activities to ensure proactive benefit-risk management throughout product life cycle



* Engage with internal stakeholders as the representative of Global Medical Safety (GMS).

ICSR Management and Oversight:


* Ensure local collection, review, reporting, reconciliation, and follow up on Individual Case Safety Reports (ICSR).



* Manage and maintain active involvement in day-to-day ICSR management related activities as applicable.



* Ensure implementation of local literature process.



* Maintain oversight of corresponding vendor activities as required.

PV Compliance Activities:


* Ensure PV audit/inspection readiness at the LOC level at all times.



* Maintain oversight of ICSR inbound and outbound compliance



* In cooperation with Medical Safety Quality (MSQ), perform ICSR reconciliations
and review c...