Roche Pharmaceuticals, India, has been disseminating scientific knowledge pertaining to innovative medicines to the medical fraternity. We have products in therapeutic areas such as Oncology, Virology, Nephrology, Transplantation, Anemia and Rheumatoid Arthritis. In recognition of its contributions in Oncology, Roche India has been awarded the Best Oncology Company of the Year, by Frost & Sullivan at the India Healthcare Excellence Awards for the years 2011, 2012 and 2014.
Post : Senior Executive/Assistant Manager - Drug Safety
Job description:
This position will assist Local Safety Responsible/Local Safety Unit (LSR/LSU) function in ensuring collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements and company policy. He/She will also assist LSR/LSU function in maintaining oversight of safety risk management and all other pharmacovigilance (PV) activities and will ensure PV compliance and inspection readiness across all affiliate functions. This position will report to the Manager – Drug Safety
- You will review, process and assess all source documents for identification, collection, validation and reporting of Individual Case Safety reports from all spontaneous and solicited sources, track all adverse event reports received and completed into the respective Pharmacovigilance tracking tools and or local trackers
- You will be responsible for review, submission, management and follow up of Individual Case Safety Reports(ISCRs) from all relevant sources according to global Roche and local regulatory requirements and Aggregate Reports to Regulatory Authorities as per global Roche and local regulatory requirements
- You will responsible for preparing and reviewing safety submission dossiers for submission to Health Authorities, co-ordinate with Roche safety and non-safety staff and will also maintain PV compliance for Roche managed Clinical Studies & Market Access program oversight in accordance to global Roche and local regulatory requirements and company policy
- You will co-ordinate with Legal, Commercial Operations, Logistics department and other cross functional teams and will be responsible for review and implementation of Local PV clauses contracts and Pharmacovigilance Agreements as per global Roche and local regulatory requirements
- You will ensure timely execution and sign off from the Licensing Partners within timelines in accordance to global Roche and local regulatory requirements and company policy
- You will ensure maintenance of all relevant Roche safety database/trackers as per global Roche and local regulatory requirements and as per company policies
Candidate Profile :
- You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
- You are a Medical/ Pharmacy/ Nursing Graduate with 3-5 years of experience in drug safety and have used tools like ARISg/ARGUS
- You have knowledge of relevant drug safety regulations (ICH, EMEA, FDA and local Regulatory Authorities)
- You have preliminary knowledge of drug development, clinical trials, regulatory and statutory requirements
- You have knowledge of ICMR, ICH, Adverse Events, Adverse Drug Reaction, Serious Adverse Event, PSUR-Periodic Safety Update Reports, SUSAR
- You have a consistent performance track record and are an excellent team player
Additional Information:
Job ID: 3396974815
Qualification: B.Pharm, B.Sc
Location: Maharashtra, Mumbai
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Drug Safety
End Date: 20th March, 2017
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