Drug Safety 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...

Minimum 1 year of experience in safety scientific writing/PSUR/PBRER/Aggregate report/Signal Provide medical, safety input and review of all required safety reports, such as- but not limited to -Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Assessment Reports (PBRERs)/Periodic Adverse Drug Experience Reports (PADERS), Risk Management Plans...

We are looking for experienced candidates for the position of Senior Drug Safety Physician with minimum 2 Years of ICSR experience.Location - Chandigarh/Mohali/Hyderabad/ Homebased Job Purpose:Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational...

We are looking for experienced candidates for the position of Senior Drug Safety Physician with minimum 2 Years of ICSR experience.Location - Chandigarh/Mohali/Hyderabad/ Homebased Job Purpose:Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational...

(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...

DescriptionPrincipal Safety & Pharmacovigilance SpecialistSyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...

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...

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions - To Prioritize...

**Job Purpose**: - Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports,...

**Job Purpose**: - Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports,...

Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United...

Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United...

Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United...

**Description** **Principal Safety & Pharmacovigilance Specialist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide...

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...

Safety Scientist II - (client embedded) 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...

**Regulatory Affairs Associate** - Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. - Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory...

**Experience: 3-5 years** The role of a Site Safety Officer is crucial in ensuring the well-being of workers and the compliance of the workplace with safety regulations.. **Salary - RS 22000/- to RS 25000/- per month** Person should know risk analysis, PPE inspection, JSA, TBT, method statemet, incident investigation and statutory laws about EHS. He must...

Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory...

Job Purpose: The Solutions Support Consultant, Safety Services works in partnership with the Solutions and Account Management Associate Director(s) and Director(s) and operational and commercial teams to optimize new business awards though the development of creative, cost-effective and high-quality competitive strategies and business solutions which...