▷ High Salary Senior Manager, Drug Safety Physician Pharmacovigilance Epidemiology
7 days ago
Job Description - To lead a team of Drug Safety Physicians working on ICSRs Projects. - Conduct initial assessment and Medical Review of ICSR s into the safety database. - Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Causality Comment. - Review and respond to any queries/comments from the Case Owner in the Safety database. - Train and mentor PV associates on event capturing and general PV conventions as required. - Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. - Escalate complex case issues on client products to Team Lead/Line Manager. - To detail any follow-up information that is required and not already noted within the Safety database. - To provide documentation of the review and case comments in Safety database in Medical Review workflow. - Maintain good knowledge of databases, regulations, guidelines and SOP s. - Maintain strong GPVP and GCP knowledge. Following ICH, EMA and FDA guidelines strongly and implementing them appropriately. - To actively communicate and participate in internal project meetings. - Participation in internal and external audits/inspections. - Perform any other drug safety related activities as assigned by PharmaLex management. - .Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. - Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety. - Strong interpersonal and organizational skills to be a good team player. - High sense of responsibility, dedication, and desire to work under pressure as required. - Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. - Good communication skills. Fluent in English- spoken and written.
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Noida, Uttar Pradesh, India PharmaLex Full time ₹ 12,00,000 - ₹ 36,00,000 per yearOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...
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Noida, India PharmaLex Full timeOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...
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Faculty (Dra or Pharmacovigilance)
6 days ago
Noida, India Pharma Regulatory Institute Full time**About Company** **Pharma Regulatory Institute (PRI)** This is a project (PRI) of Accredited Consultants Pvt. Ltd. (ACPL), Noida who are very well established in the business of Regulatory Affairs and Pharmacovigilance for the last 25 years and created a very strong image in the industry. ACPL clients are widely distributed in Foods, Pharmaceuticals,...
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Drug Safety Physician
2 weeks ago
Noida, Uttar Pradesh, India Apcer Life Sciences Full timeManage daily workload in conjunction with Manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department. - Medical review of ICSRs in APCER’s Pharmacovigilance database and aggregate reports for the purpose of expedited/periodic submission as per the Regulations...
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Pharmacovigilance Trainee
2 weeks ago
Delhi, Gurugram, NCR, Noida, India Syneos Health Full time ₹ 9,00,000 - ₹ 12,00,000 per yearKickstart Your Career in PharmacovigilanceSyneos Health is hiring Safety & Pharmacovigilance Trainees for 2024/2025 passouts in:M.Pharm Pharm.D BHMS BDS M.Sc + B.Pharm Ph.D. (Pharmacy) Location: Gurugram, India Deadline: August 23, 2025 (just hours left) Join a global biopharma leader with 29,000 employees across 110 countries. Work on real-world drug...
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Noida, India World Courier Full timeJob Description Job Details - Preparation of responses to PRAC assessment reports and other Authority requests (e.g., referrals, etc). - Performing signal detection and signal analysis of safety data, provide the appropriate expert advice as well as assisting in communication with regulatory agencies when the new data has an effect on the risk-benefit...
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Gurugram, New Delhi, Noida, India Resolve Medicode Full time ₹ 15,00,000 - ₹ 25,00,000 per yearClinical trials is a crucial field in the pharmaceutical industry focused on drug safety. Professionals in this area monitor, assess, and prevent adverse drug reactions to protect public health.Qualification & Specifications :MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T,...
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Senior Manager
2 weeks ago
Noida, Uttar Pradesh, India PharmaLex Full time ₹ 20,00,000 - ₹ 25,00,000 per yearOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...
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Clinical Safety Physician
2 days ago
Bengaluru, Mumbai, Noida, India Tata Consultancy Services Full time ₹ 8,00,000 - ₹ 20,00,000 per yearTCS is Hiring -Clinical Safety Physicianlocation - Mumbai, Noida, BengaluruExperience Range - 5 to 10Preferred Educational Qualification for the role - MBBS/MDJob DescriptionLiterature ReviewLiterature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).Provide MAH comments for selected...
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Pharmacovigilance Trainer
2 weeks ago
Noida, India Uptoskills Full time**Responsibilities**: - Develop and deliver pharmacovigilance training programs for students. - Conduct assessments and evaluations to measure the effectiveness of training sessions and identify areas for improvement. - Provide ongoing support and guidance to trainees on pharmacovigilance-related queries and issues. - Actively participate in the development...
