Drug Safety Associate

**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...

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...

**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...

The Medical Information Associate is responsible for providing technical and scientific information to healthcare professionals, consumers, and internal staff on a wide range of pharmaceutical medicines, OTCs, medical devices and therapeutic areas, including conducting complex literature searches and reviews using various medical database. Also responsible...

(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...

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...

**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...

**Responsibilities**: - Assist in the planning, execution, and monitoring of clinical research studies. - Ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. - Monitor and report adverse drug reactions (ADRs) and other pharmacovigilance activities. - Conduct literature reviews and safety signal assessments. - Maintain...

Job Overview - Maintain a repository of, and communicate on, international, regional and national legislations, recommendations and guidelines related to vigilances for all ranges of products such as medicinal products, medical devices, cosmetics, nutraceuticals. - Appropriately identify and address potential regulatory issue that may have an impact on the...

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...

This job is with Parexel, 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 Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to...

We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety. **Responsibilities**: Clinical Phase: - Lead as a medical monitor/Medical expert - Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as...

Primary point of contact between site staff and NN. Acts as ambassador for the company and contributes to making NN the preferred partner. Responsible for managing the site to meet patient recruitment rate and target. Delivers results that have direct impact on the successful completion of the clinical program. Coordinates with PM and communicates to them...

Case processing - cases in Japanese Language

PhD or Master in Statistics or related discipline with relevant experience of 5 - 8 Years. - Expericence in bioanalytical & pharmacokinetic studies. - Contributes to statistical strategies for nonclinical and clinical bioanalytical assay development, GLP and non-GLP drug safety studies like study design, protocol development, SAP, trial design, protocol and...

In Parexel FSP we are currently looking for a Site Relationship Partner based in Mumbai, India. **Position Purpose**: - The Site Relationship Partner (SRP) is the main Client point of contact for investigative sites, responsible for building and retaining relationships from site activation through the lifecycle of studies - The SRP is the face of the...

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...

(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...

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of...