Pharmacovigilance Associate
5 hours ago
Come join a world renowned, global pharmaceutical corporation If you are an experienced **Pharmacovigilance Associate** with excellent communication skills and the following skills, we would love to speak with you The **Pharmacovigilance Associate** will help support the establishment of the future Local Safety Organization by reviewing current processes/ regulations and develop strategies to implement required distribution rule changes to establish a compliant and effective PV system for a new consumer organization. This position primarily supports the reporting requirements to Global as well as Local Health authorities along with establishment of the future Local Safety Organization. The Pharmacovigilance Associate will review current processes and develop strategies to implement required changes to distribution rules to establish a compliant and effective PV system for the new Consumer organization. Also providing functional oversight of case management activities performed at contracted vendor organizations. Collaborating with staff across various functions within the Consumer Health business as well as across other sectors to facilitate compliant, timely, and efficient execution of regulatory reporting requirements. **Key Responsibilities**: - Responsible for functional oversight and execution/ validation of reporting rules on local as well as global level for consumer portfolio of products - Liaising with Local Safety Office to understand and identify requirements for local reporting requirements for various regions - Identifies and implements process efficiencies and continuous quality improvements to support business objective of cost-efficient sustainable and scalable end to end case management solutions - Develop standard operating procedures, work instructions and training to support reporting activities and ensuring vendor is adequately trained on requirements - Supports the Director in internal audits and external inspections and develops corrective and preventative actions to address non-conformances - Participates in cross-functional governance teams to ensure alignment of priorities among key business partners - Performs other related duties as the need arises **Requirements**: - Demonstrate good knowledge of regulatory reporting requirements globally - Demonstrated experience working in a matrix environment and cross-functional teams - Practical knowledge of global regulatory pharmacovigilance requirements - Understanding of medical terminology and ability to summarize medical information - Ability to view the "big picture" and understand impact of decision taken within the team or function - **Education**: - A minimum of bachelor’s degree in life sciences or health-care field with 5-8 years’ experience in Pharmacovigilance OR - Advanced degree (e.g., MS, MPH, PharmD, or PhD) with 5 years of experience in Pharmacovigilance or related activities industry activities preferred OR - Advanced degree with completion of a 2-year Pharmacovigilance fellowship. **Preferred**: - Working knowledge of safety databases to identify system enhancements and efficiencies including MedDRA and product dictionaries and version updates - Experience working on CAPAs is strongly preferred - Experience authoring and editing controlled documents (e.g., SOPs) is strongly preferred - Experience overseeing vendors and local safety units is strongly preferred
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Pharmacovigilance Associate
6 hours ago
Mumbai, Maharashtra, India Cliniweb Services Full timeA pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...
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Pharmacovigilance Associate
2 weeks ago
Andheri, Mumbai, Maharashtra, India Clariwell Global Services Full timeA pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...
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Pharmacovigilance Associate
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Mumbai, Maharashtra, India Vertex Business Solutions Full time**Job description** **Responsibilities**: - Receive, review, and process adverse event reports and other safety information in accordance with established procedures and timelines. - Perform case assessment and documentation, including the identification of potential safety concerns and relevant medical information. - Ensure the quality and integrity of...
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Senior Specialist, BT Pharmacovigilance
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Mumbai, India Organon Full timeThis job is with Organon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Job Description The Position The Senior Specialist, BT Pharmacovigilance will report directly to the Director of Pharmacovigilance Business Technology and will be a key member...
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PV Associate
1 week ago
Mumbai, Maharashtra, India ClinXcel - Academy of Clinical Research Full time ₹ 9,00,000 - ₹ 12,00,000 per yearCompany DescriptionClinXcel is a leading training and consulting organization specializing inClinical Research, Pharmacovigilance, Clinical Data Management, and Regulatory Affairs. We deliverpractical, job-ready training solutionsand expert consulting services, including PV operational support, audit & inspection readiness, and regulatory compliance.Role...
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Mumbai, Maharashtra, India Talisman HR Solutions Full timeDesignation Pharmacovigilance Associate Education M pharmacy Experience Fresher or experience Pharma Industry Salary Best in industry Job Location BKC Mumbai Note This role will be on payroll of Talisman HR Solution Core Job Responsibilities Assist ASR in conducting Basic PV Training of company staff i e by assigning training and tracking compliance Send...
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Drug Safety Associate
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Navi Mumbai, Maharashtra, India Global IT Solutions Full timeCompany DescriptionSince 2007, Global IT Solutions has been a leading strategic manpower sourcing agency, specializing in placements for IT and ITES companies across India. Our team consists of highly experienced recruiters with extensive knowledge in various business domains. We have consistently demonstrated a success rate ranging from 70% to 80% in...
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Mumbai, India Seven Consultancy Full timeJOB DETAILS One of our clients, a reputed company in medical & healthcare industry, is seeking a Drug Safety Associate to join their growing team. In this position, you will be responsible for 1. processing and oversight of a. (AE) adverse event/drug experience reports (serious and non-serious) and b. other safety-related data for Incite marketed...
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Pharmacovigilance Associate
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Mumbai, Maharashtra, India Clariwell Global Full timePerform case processing of Adverse Event (AE) reports from various sources (spontaneous, literature, clinical trials). - Enter and update safety data into safety databases with accuracy and timeliness. - Assist in narrative writing and medical coding of adverse events using MedDRA. - Conduct literature screening for safety information as per regulatory...
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For Life Science As Gm/dhm for Mumbai
1 week ago
Navi Mumbai, India Orcapod Full time**Roles and Responsibilities** **Hiring for Life Science as GM/DHM for Mumbai** **Warm Regard from Orcapod Consulting Services!!** **Job Discerption** **Role: Transition GM / D** **Location: Mumbai** **Experiance: 18-30yrs** **Qualifications:Any Graduate. PMP certification is preferred.** **1. D - 18-22 Years exp generic & 10+ Years Core Life...
