MedHimalayas is a technologically advanced, contract research organization (CRO) which has been set up with an aim to deliver services of highest quality in clinical research, pharmacovigilance, regulatory, medical writing and clinical data management.
Headquartered in UK, MedHimalayas has its operational centers in Hyderabad and Mumbai in India.
Post: Pharmacovigilance Manager
Job Description:
To lead the team and ensure accurate and timely processing of pharmacovigilance cases.
To manage the evaluation of pharmacovigilance data received in the team and to ensure potential pharmacovigilance issues are dealt with appropriately.
To ensure accurate and timely communication between relevant departments within the company and UK Pharmacovigilance Department.
To ensure that all processes and data are kept in an inspection and audit ready condition at all times.
To build and maintain the high performing drug safety team, ensuring the quality and compliance of SOP’s
To ensure timely resolution of safety related issues and or escalation to Affiliate Pharmacovigilance Head.
To deputize for the Affiliate Pharmacovigilance head when appropriate.
To respond and record all details of Medical Information queries in an accurate and consistent manner.
Be responsible for providing medical evaluation for case assessments and ensure correct assignment of seriousness for cases received within the company.
To prepare Periodic Safety Update Reports, Bridging Summaries and Cumulative ADR Summaries.
To review the worldwide literature for suspected ADRs upon request.
To assist in the training of appropriate personnel in the relevant aspects of Pharmacovigilance in special projects undertaken from time to time to ensure objectives and deadlines can be met.
Assisting with any other Pharmacovigilance/Medical Information team projects as necessary.
Candidate Profile:
You will be preferably a medical or life sciences graduate with demonstrated experience in a Global or European Pharmacovigilance / Clinical Safety environment.
Experience with global safety databases, MedDRA coding, E2B reporting, PSURs, risk management.
Experience in medical and scientific review of documents is required.
Track record of management of pharmacovigilance projects in a similar background.
Additional Information:
Experience: 3-6 Years
Location: Hyderabad
Education: B.Pharm, M.Pharm, MS, MD
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 12th Oct., 2011
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