Job for M.Pharm, B.Pharm at Johnson & Johnson as Local Safety Officer

Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments.

Post : Local Safety Officer

Job Description

To ensure highest compliance in collection (initial and follow-up), review, reporting and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.
Accountable internally for ensuring that the LOC meets procedurally defined timelines for management of safety information and local regulatory agency defined timeline for submission of individual reports.
To ensure that data generating activities are reviewed for any solicitation for information and to ensure appropriate reporting of potential AEs (e.g. patient support programs, market research surveys, internet sites)
Assure the all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
Collaboration with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs (PSP) to ensure appropriate safety reporting to GMS or appropriate case management centre and RA, as required.
Plan and ensure timely submission of Aggregate Reports according to local regulations
Provide local data as required to support the preparation of Aggregate Safety Summaryreports (PSUR, DSUR, etc.).
Identify local Medical/Scientific Literature not available to GMS, review for AEs and report as required per literature reporting criteria.
Ensure that day-to-day PV functions are performed satisfactorily and that optimal regulatory compliance is maintaind at the Janssen LOC level.
Ensure PV inspection readiness on the LOC level at all times.
Ensure proper documented training on drug safety reporting responsibilities of Janssen LOC personnel and maintenance of awareness of drug safety reporting in general
Ensure implementation of Global and Cross-Pharma Procedural Documents as applicable

Candidate Profile
Qualification: MBBS, B. Pharm, M. Pharm, Post Graduate in any discipline of Medicine
Experience: Minimum of 2-3 years of experience in Pharmaceutical industry and Pharmacovigilance.

Additional Information:
Experience:- 2-3 years
Qualification: B.Pharm, M.Pharm, MBBS
Location: Mumbai
Department: Pharma
Job Function: Pharmacovigilance
Requisition ID: 1700169422W