Safety Regulatory Intelligence Associate

The primary duty of a Drug Safety Associate involves the ongoing monitoring and evaluation of adverse effects and safety concerns associated with drugs and medical products following market approval. As a Drug Safety Associate, your responsibilities will include monitoring, assessing, and reporting adverse events related to pharmaceutical products. You will...

(India) Looking for experienced regulatory writers **As we are expanding our team, we are thrilled to announce that we are looking for experienced Indian regulatory writers to join our dynamic, collaborative team to engage with biopharmaceutical clients and prepare clinical and safety regulatory documents. This is a full-time, remote, salaried...

(India) **About Us** Kateric is a strategic partner for biopharmaceutical companies that consistently delivers superior quality regulatory documents through excellence, experience, and intelligent execution. Kateric’s resources are located across multiple time zones in the United States, as well as in India, the EU and Canada, and also have experience...

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

Coordinates the timely review of serious and non-serious adverse events; tracks all necessary data and generates reports for the client, project team and/or external vendors. - Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project...

Summarized Purpose: Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not limited to delivery...

**Career opportunity** **Consultant - Medical Device Regulatory and Clinical Affairs** **Project Associate - Remote, India **compliance with international regulatory requirements. We serve clients with hands-on support for compliance with applicable regulatory requirements of our clients’ target markets. Our services cover all steps of Medical Device and...

Responsibilities In the context of a project for one of our top Pharma client, we’re looking for 2 talented Regulatory Affairs Officer to lead the following missions, and much more! Compile, or supervise the compilation of regulatory dossiers Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for...

**Job Title**:Pharmaceutical Regulatory Affairs Executive **(Intern)** **Location**: Pune, India **Duration**: 9 months (Advanced Certification) + 3 months (On the Job Internship) **Job Summary**: **Key Responsibilities**: 1. Attend classes on weekends (Saturdays and Sundays) 2. Complete coursework, assignments, and projects 3. Participate in...

Responsible for receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. Assists management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects. Essential Functions Receives, prepares and submits...

**Job Purpose**: Principal Safety Physician is responsible for performing medical & safety monitoring tasks in the assigned projects and contribute to medical review, analysis and guidance in all required safety reports. Principal project teams, business development and pre-award activities. - Provide medical review, analysis and guidance during the case...

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

**Description** **Senior Safety & Pharmacovigilance Submissions Specialist** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...

**Job Description**: - 4-6 yrs of experience in handling of pre and post approval life cycle management of Biologic products in various markets Regulated (EU/US/Canada) and Emerging Markets. - Experience of support the compiling, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes). Contribute to preparation...

**Employee Benefits**: We invest in our Team. Our benefits cultivate a growth-centric environment. **Meaningful Equity** - ESOPs are available for top performers across all levels**Competitive Compensation** - Our salary formula adjusts to your cost of living and experience along with performance-based bonus programs in all departments**Work Remotely** - We...

**Employee Benefits**: We invest in our Team. Our benefits cultivate a growth-centric environment. **Meaningful Equity** - ESOPs are available for top performers across all levels**Competitive Compensation** - Our salary formula adjusts to your cost of living and experience along with performance-based bonus programs in all departments**Work Remotely** - We...

Premier Research is looking for a Site Start Up Associate 1 to join the SSU Team in India. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are...

**Responsibilities**: - To contribute to the production of client administrative documents and reports to be included in regulatory submissions - Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements - LCM, Systems Management and Administration - Document and track regulatory submissions and regulatory...