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Local Safety Officer Post for Pharma Candidates @ Johnson & Johnson

Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives.

Job Title: Local Safety Officer

No of Posts: 01

Salary: As per company standards

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

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About Vaishali M R

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