Drug Safety Physician / Medical Reviewer Synowledge PV Services India Pvt Ltd

JOB TITLE: Drug Safety Physician/ Senior Drug Safety Physician

LOCATION: Mysore, India

YEARS OF EXPERIENCE: 0-5 years experience in PV

EDUCATION: MBBS/ MD (Any)

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

As a Medical Reviewer

Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
Determine seriousness and relatedness across products as assigned
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
Acquire and maintain knowledge of applicable Global Health Authority regulations
Perform any other drug safety related activities as assigned
Participate in internal and external audits and inspections by clients and health authorities


SPECIALIZED KNOWLEDGE AND SKILLS:

Experience with relevant safety databases and related software applications
Proven experience in customer handling and relationship.
Proven ability to perform task management.
Must have good presentation skills and the ability to give presentations.
Knowledge of the Life Sciences Industry and life cycle of drug.
Relevant product and industry knowledge.
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Opening for Medical Writing for M.pharm/pharm.d Freshers,experienced

 Hiring for freshers -M. Pharm/ Pharm. D at Indegene Lifesystems for Scientific Writing/ Medical Writing.


Kindly find the job description.
Develop content for various deliverables meeting quality requirements as per client satisfaction metrics, with active guidance from the manager

Responsible to develop content as per the timelines assigned

Responsible to follow the best practices in the department regarding - processes, communication (internal & external), project management, documentation and technical requirements like - language, grammar, stylization, content search, summarizing, data conflicts and referencing

Participate in assigned training programs and work on assignments as per requirement

Participate in cent calls as per project requirements

Compliance to quality, confidentiality and security:

Adhere and follow quality systems, processes and policies

Comply to training and specifications


Education : M.Pharm/ Pharm. D - Freshers

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Pharmacovigilance Medical & Scientific Writer With Crest - Pune

• Identifying and evaluating individual case safety reports (ICSRs) of adverse drug reactions from the published literature
• creating summary content in a range of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing ) to support the drug safety reporting and information requirements of pharma industry clients
• Required background and experience: you will have working experience in the pharmacovigilance/drug safety field and a background in medicine or pharmacy
• Ideal experience would include:
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• Scanning the literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
• Detailed evaluation of individual case reports e.g. determining seriousness of adverse events, determination of drug causality, subsuming signs and symptoms into clinical diagnoses etc.
• Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities

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Process Trainer (pharmacovigilance)-Cognizant Mumbai

• Deliver training on the floor - effectiveness measured through Trainer Feedback Score (from Trainees)
• Ensure associates are assigned to process training refreshers based on QA data on associates performance
• Facilitate Process Training Refresher modules effectively measured through Trainer Feedback Score
• Ensure completion of all compliance courses for all associates tagged to the project within timelines
• Willingness to work in rotational shifts
  Only BPharm/MPharm/BDS/BAMS/BHMS candidates need to apply 

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