
Pharmacovigilance Associate
4 days ago
- Perform 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 requirements.
- Ensure compliance with global regulatory requirements and internal standard operating procedures (SOPs).
- Support in preparing periodic safety update reports (PSURs) and risk management documents.
- Collaborate with cross-functional teams such as medical writing, regulatory affairs, and clinical research.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, Nursing, Biotechnology, or related discipline.
Job Types: Full-time, Permanent, Fresher
Pay: ₹360, ₹578,383.71 per year
Benefits:
- Health insurance
- Paid sick time
Work Location: In person
-
Regulatory Affairs Specialist
1 week ago
Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 8,00,000 - ₹ 12,00,000 per yearThe role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile will ensure timely and robust functional/crossfunctional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent executionand implementation of regulatory affairs and safety processes.Local Regulatory...
-
Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India CliniLaunch Research Institute Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile will ensure...
-
Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 15,00,000 per yearPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...
-
Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile will ensure...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 12,00,000 per yearPosition:Sr. Executive / Asst. Manager / Deputy Manager – Regulatory Affairs (Domestic)Location:Andheri, MumbaiQualification:M. Pharm. (Experienced preferred)Job Description – Regulatory Affairs (Domestic)The role requires strong expertise in theDrugs & Cosmetics Act and Rules,FSSAI regulations, andFDA-related activities. The profile will ensuretimely...
-
Safety Writer
4 days ago
Mumbai, Maharashtra, India Fortrea Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Overview:Responsible for the preparation and review of aggregate safety, risk management, and signal detection documents. Perform report management activities and lead client communication for the assigned reports. Assist other medical writers in their safety deliverables, act as a co-author for complex or large reports. Provide oversight and quality...
-
Pharmacovigilance Associate
1 week ago
Mumbai, India Statistical Pharma Full time**Job description** - Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable) - Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners - Supports PV Clinical Specialists in tasks and projects as needed - Responsible for identifying and developing...
-
Pharmacovigilance Associate
6 days ago
Mumbai, Maharashtra, India Statistical Pharma Full time**Job description** - Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable) - Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners - Supports PV Clinical Specialists in tasks and projects as needed - Responsible for identifying and developing...
-
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...
-
Pharmacovigilance Associate
3 weeks ago
Mumbai, 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...
-
For Life Science As Gm/dhm for Mumbai
16 hours 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...
-
Oracle Argus Functional associate
2 weeks ago
Mumbai, India Anicalls (Pty) Ltd Full time• Must have a combined experience of 10 years in Business Analysis and hands-on Experience in Oracle Argus safety doing the following: • Strong BA skills with extensive Experience as a BA. BA experience with safety applications like Argus, ARISg, etc. will be beneficial. • Excellent Experience of Oracle Argus Safety, which includes configuration,...
-
Medical Advisor
3 weeks ago
Mumbai, India Scaleneworks Full timeLooking for Medical Advisors for - 1.Diabetes Care 2.Oncology+ Haematology Medical Advisor Diabetes Care & Oncology+Haematology We are hiring Medical Advisors to join our client, with openings in Oncology and Diabetes Care. These roles are strategic and scientific in nature, providing medical leadership, cross-functional collaboration, and thought leader...
-
Mumbai, India Seven Consultancy Full timeJOB DETAILS One of our clients, a reputed company in clinical research, is looking out for a Clinical Research Associate for their office based in Mumbai. The job responsibilities are as follows: 1. Act as monitor of specific sites on a clinical study, under supervision, as appropriate. 2. Facilitate preparation and collection of site level documents. 3....
-
Team Member
2 weeks ago
Vikhroli, Mumbai, Maharashtra, India Cipla Full time**Division**: - Quality**Department**: - Quality**Employment Type**: - Permanent**Job Purpose**: Provide healthcare professionals and patients with complete and impartial information and minimize potential risks associated with Cipla products to comply with the regulatory requirements and guarantee safety of our medical products **Accountabilities**: I....
-
Officer - PV- Medical writer
3 weeks ago
Mumbai, India Unichem Laboratories Full timeRESPONSIBILITIES Responsible for management of scheduled and unscheduled aggregate reports including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), United States Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plan (RMP), Health Hazard Evaluation (HHE)....