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

 

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Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Post: Local Safety Officer-1500055099W

Job Description
Johnson & Johnson – Pharma: Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India. Driven by a strong commitment to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas.

Job Title (India Specific): Local Safety Officer
Location: HO, Mumbai

Purpose of the position:
The purpose of the position is to ensure that the LOC Pharmacovigilance activities are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any Pharmacovigilance agreements with third party business partners.

General Responsibilities:
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 Summary reports (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 maintained 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

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Qualification:
MBBS, B. Pharm, M. Pharm, Post Graduate in any discipline of Medicine
Experience
Minimum of 2-3 years of experience in Pharmaceutical industry
Target organizations – Pharma

Reporting Relationships:
Reports to (Role): Manager-Pharmacovigilance
Direct Reports (Role & Number): None

Additional Information:
Experience: 2-3 years
Qualification: B.Pharm, M.Pharm
Location:
Mumbai
Functional Area: Pharmacovigilance
Industry Type: Pharma/Biotech/Clinical Research
End Date: 10th October, 2015

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