At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
Post: Associate Medical Safety Advisor - 1
PURPOSE
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.
RESPONSIBILITIES
• Medical evaluation of individual adverse event case safety reports, including but not limited to all serious, non serious line listings, expedited reports and all pregnancy reports.
• Accountable for review and interpretation, analysis and summarization of aggregate safety data from all sources including spontaneous, clinical, post-marketing and observational studies, literature review and product quality, (e.g. RMP, PSUR, ad-hoc regulatory reports, etc)
• Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing a Pharmacovigilance Physician product team and/or technical leadership in single case assessment.
• Ensuring service delivery from productivity, compliance and quality perspective. Lead and participate in the initiatives taken for the same from team delivery perspective.
• Participate in signal detection efforts, e.g. strategy meetings for PSURs and periodic reports and structured surveillance programs and execution of pharmacovigilance components of Risk Management Programs and related activities including assessment of potential signals
• Ensuring updation of watchlist, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team
• Responsibilities include lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives
• Lead or participate as members of pharmacovigilance matrix-teams responsible for pharmacovigilance activities focused on individual products and therapeutic areas.
• Responsibilities include, participation in selected reviews of aggregate reports such as PSURs, PADERS, contributing to the development and implementation of risk minimization action plans, as applicable etc.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Sound knowledge of Medicine
• In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Knowledge of Pharmacovigilance- ICSR and Aggregate reports
• In-depth knowledge of departmental standard operating procedures (SOPs)
• Skill in use of multiple safety databases
• Adequate Computer skills, especially Microsoft word, excel & PowerPoint.
• Good communication skills- verbal and written
• Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
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Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Medical degree (MBBS 5.5 year degree including compulsory internship of 1 year) and Board Certified/Board Eligible or equivalent post-graduate training in a recognized medical specialty from a recognized university. At least 3 years of clinical practice following completion of internship is preferred. 1 - 2 year’s pharmaceutical industry experience preferred
PHYSICAL REQUIREMENTS
• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.
Additional Information:
Qualification: Medical degree
Location: India
Industry Type: Pharma
Functional Area: Drug Safety/Pharmacovigilance
End Date: 30th November, 2017
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