
Pharmacovigilance Manager
16 hours ago
Designation
: Asst Manager/Manager – Medicoregulatory Affairs
Department
: Medicoregulatory Affairs
Job location :
Kandivali-West, Mumbai
Responsibilities
I To independently review following applications online through Sugam Portal to CDSCO:
- Import license of reference product for BE studies
- BE study NOC for export purpose
- Manufacture of new drugs to be introduced for the first time in India or to undertake clinical trial
- Manufacture of fixed dose combination
- Protocol amendment of clinical trial
- Clinical trial site addition/ deletion/ closure or change in principal investigator
- NOC for Form 29 for clinical trial samples
- Manufacture of new bulk drugs (API)
- Marketing of an already approved drug with new indication
- Marketing of an already approved drug as a new dosage form or new route of administration
- Marketing of an already approved drug as modified release dosage form.
- Marketing of an already approved drug with additional strength
- Export of biological sample
- NOC for Form 29 for development purpose
- Permission to manufacture and export API.
II. To review updated pack inserts
III. To review therapeutic rationale
IV. To review patient information leaflet
V. To initiate PIF
VI. To handle regulatory queries from various departments
VII. To screen updation of Indian regulatory guidelines on weekly basis
VIII. To prepare SOPs for Medicoregulatory Section
Qualification
- M Pharmacology
Experience
years.
-
Pharmacovigilance Expert
2 days ago
Mumbai, Maharashtra, India beBeePharmacovigilance Full time ₹ 15,00,000 - ₹ 28,00,000Job DescriptionThe Pharmacovigilance Professional is responsible for the collection, management, and analysis of adverse event reports from various sources. They will also contribute to the development and implementation of new safety-related systems, processes, and procedures.Key responsibilities include analyzing complex data, ensuring compliance with...
-
Mumbai, Maharashtra, India beBeePharmacovigilance Full time ₹ 1,04,000 - ₹ 1,30,878Medical Reviewer PositionWe are seeking a Medical Reviewer to join our team at the Pharmacovigilance department of our organization.The ideal candidate will have MBBS degree and 0-2 years of experience in Pharmacovigilance department (ICSR/Aggregate reports).Freshers may be considered for Assistant Manager position, and immediate joiners will be given...
-
Clinical Safety Manager- Pharmacovigilance
1 week ago
Mumbai, Maharashtra, India Medpace Full timeJob SummaryOur clinical operations activities are growing rapidly and we are currently seeking a full-time Clinical Safety Manager to join our Clinical Safety Department in India This position plays a key role in the pharmacovigilance process at Medpace If you want an exciting career where you use your previous nursing or pharmacovigilance expertise and...
-
Drug Safety Expert
2 weeks ago
Mumbai, Maharashtra, India beBeeRisk Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Job Title:Drug Safety Expert - Pharmacovigilance LeadKey Responsibilities:- Serve as the company's subject matter expert on drug safety and pharmacovigilance, ensuring compliance with Local & Global PV-relevant Heath Authority requirements.- Oversee pharmacovigilance contracts, vendor management, and system audits/inspections, demonstrating good...
-
Data Entry Specialist
7 days ago
Mumbai, Maharashtra, India beBeePharmacovigilance Full time ₹ 8,64,000 - ₹ 14,40,000Job Description:As a Pharmacovigilance Officer, you will be responsible for managing and processing safety reports, ensuring compliance with regulatory requirements, and providing excellent customer service to clients.Responsibilities:Manage the receipt, processing, and tracking of all safety information received from clients.Perform quality control checks...
-
Mumbai, Maharashtra, India beBeeClinicalResearchManager Full time ₹ 72,32,000 - ₹ 90,40,000Senior Manager Clinical ResearchA highly accomplished Senior Manager Clinical Research is required to oversee the management of clinical trials, pharmacovigilance, and medical writing projects in Mumbai.Key Responsibilities:Clinical Trials ManagementPharmacovigilanceMedical WritingThe ideal candidate will possess an MBBS + MS/ MD degree and relevant...
-
Safety Expert
7 days ago
Mumbai, Maharashtra, India beBeePharmacovigilance Full time ₹ 9,00,000 - ₹ 12,00,000Job Description:We are seeking a skilled and detail-oriented Pharmacovigilance Professional to join our team. The successful candidate will be responsible for managing end-to-end case reports, including receipt, follow-up, database entry, and submission to regulatory authorities.This role involves mailbox management, tracking of individual case safety...
-
Chief Risk Management Specialist
4 days ago
Mumbai, Maharashtra, India beBeePharmacovigilance Full time ₹ 1,72,80,000 - ₹ 2,59,20,000Job DescriptionAs a Senior Pharmacovigilance Leader, you will oversee the development and implementation of comprehensive risk management plans to ensure compliance with local and global PV regulations. You will lead cross-functional teams in signal detection, benefit-risk evaluations, and safety data assessments.The ideal candidate will have advanced degree...
-
Junior Data Analyst
4 weeks ago
Mumbai, Maharashtra, India Cognizant Full timeJob SummaryWe are seeking a dedicated Senior Process Executive for CDM PV with 2 to 4 years of experience The ideal candidate will have strong technical skills in MS Excel and a background in PV Case Processing Pharmacovigilance and Safety Ops or Research and Development This role involves ensuring data accuracy compliance and contributing to the overall...
-
Lead Clinical Research Manager
3 days ago
Mumbai, Maharashtra, India beBeeClinicalResearch Full time ₹ 70,00,000 - ₹ 90,00,000Job Title: Senior Manager Clinical ResearchOur esteemed organization seeks an experienced Senior Manager Clinical Research to join their team based in Mumbai.The ideal candidate will possess a strong educational background with an MBBS + MS/ MD degree in any specialization.Main Responsibilities:Clinical TrialsPharmacovigilanceMedical WritingAbout the...