Drug Safety Associate II
1 week ago
When our values align, there's no limit to what we can achieve.
The Drug Safety Associate II will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Key Accountabilities :
Drug Safety Support :
Assist in development of project specific safety procedures, workflows and template Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing Triage incoming reports for completeness, legibility, and validity Electronic documentation and quality control of drug safety information Data entry of case reports into safety database / tracking system Request follow-up and perform query management Coding of data in the safety database Writing case narratives Create and maintain project specific working files, case report files and project central files Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities Participate in client and investigator meetings as required Attend internal, drug safety and project specific training sessions Perform literature searches Preparation for, participation in, and follow up on audits and inspections Delegate work as appropriate to Drug Safety Assistants Assistance in development of Expedited Reporting Procedures Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy) Submission of safety reports to investigators via ISIS (International Safety Information System) Assist with measuring investigative site performance in conducting required tasks in ISIS Tracking and filing of submission cases as required Assist with unblinding of SUSARs, as required Support collection and review of metrics for measuring reporting complianceSkills :
Analytical and problem-solving skills Able to perform database/literature searches Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Experience with computer applications
Knowledge and Experience :
Education :
Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience Associates degree in any of the above with appropriate work experience-
Drug Safety Associate I
2 weeks ago
Sahibzada Ajit Singh Nagar, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Key Accountabilities :...
-
Senior Drug Safety Physician
3 weeks ago
Sahibzada Ajit Singh Nagar, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. 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 and marketed products Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists...
-
Principal Drug Safety Physician
4 weeks ago
Sahibzada Ajit Singh Nagar, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Principal Drug 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 Drug Safety Physician is also responsible for providing medical...
-
Drug Safety Associate II
1 month ago
SAS Nagar (Mohali), India Parexel Full timeJob Description: -Key Accountabilities:Drug Safety Support:Assist in development of project specific safety procedures, workflows and templateAssist in project specific safety database setup, development of data entry guidelines, and user acceptance testingTriage incoming reports for completeness, legibility, and validityElectronic documentation and quality...
-
Medical Writer II
4 months ago
Sahibzada Ajit Singh Nagar, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. 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...
-
Clinical Database Programmer II
1 month ago
Sahibzada Ajit Singh Nagar, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Job Purpose The Clinical Database Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies....
-
Pharmacovigilance Associate
5 months ago
Balaji Nagar, Pune, Maharashtra, India Vertex Business Solutions Full timeA Pharmacovigilance Associate plays a crucial role in ensuring adherence to relevant regulations and standard operating procedures. They oversee processes to ensure the effectiveness of drugs while minimizing adverse effects in both research trials and hospital settings. **Responsibilities**: - recording and reporting adverse reactions received from...
-
Medical researcher
3 weeks ago
Sahibzada Ajit Singh Nagar, India FINVASIA Full timeJob Profile- Medical Research Associate. Job Location- Mohali Company Link- About the Company: Finvasia is a multi-disciplinary, multinational organisation that owns and operates over a dozen brands across financial services, technology, real estate and healthcare verticals. Some of the notable brands owned by Finvasia are Fxview, Shoonya, ACT Trader,...
-
Medical Researcher
3 weeks ago
Sahibzada Ajit Singh Nagar, India FINVASIA Full timeJob Profile- Medical Research Associate. Job Location- Mohali Company Link- About the Company: Finvasia is a multi-disciplinary, multinational organisation that owns and operates over a dozen brands across financial services, technology, real estate and healthcare verticals.Some of the notable brands owned by Finvasia are Fxview, Shoonya, ACT Trader,...
-
Safety Officer
1 month ago
Thygaraj Nagar, India Bion Analytx private Limited Full time**Job description** Perform risk assessments before commencing any project, especially for the installation of CCTV, access control, or fire alarm systems. Identify potential hazards associated with electrical work, heights, or confined spaces during the installation of systems. Implement preventive measures to mitigate risks, ensuring safe working...
-
DevOps Associate
5 months ago
Sahibzada Ajit Singh Nagar, India Advaya Fleet Inc Full timeExperience required: 2 - 4 Years About the company:At Advaya, we are at the forefront of revolutionizing the fleet management industry, redefining uniqueness, and shaping exclusivity. With a passion for innovation and a commitment to excellence, we provide cutting-edge solutions tailored to meet the diverse needs of our clients. Our comprehensive approach,...
-
Head of product marketing
3 weeks ago
Sahibzada Ajit Singh Nagar, India CHANDIGARH UNIVERSITY Full timeResponsibilities of Head / Associate Director – Product Marketing • Lead the end-to-end product lifecycle management of university all clusters and programs • Market Research: Conduct in-depth market research to understand industry trends, competitive landscapes, product trends and customer needs. • Market Research: Gather insights to inform...
-
Head of Product Marketing
2 months ago
Sahibzada Ajit Singh Nagar, India CHANDIGARH UNIVERSITY Full timeResponsibilities of Head / Associate Director – Product Marketing • Lead the end-to-end product lifecycle management of university all clusters and programs • Market Research: Conduct in-depth market research to understand industry trends, competitive landscapes, product trends and customer needs. • Market Research: Gather insights to inform...
-
Safety Officer
5 months ago
Vaishali Nagar, Jaipur, Rajasthan, India Career Hollic Full time**Job Title - Safety Officer** **Qulification - Graduate** **Experieance - 2 to 3 years in safety office** **Good communication skills** **Salary - Up to 25k** **Location - Vaishali nagar, Jaipur** **Job Summary -** As a safety officer, your role is crucial in ensuring that workplaces, public spaces, or other environments adhere to safety regulations...
-
Revenue Officer
5 months ago
Vasanth Nagar, Bengaluru, Karnataka, India Attica Gold Pvt Ltd Full time**RESPONSIBILITES**: - Clinical testing of a new drug against an existing drug to ultimately show the new product’s superior benefits. - Providing quality data for dossier submission / registration of drug product as per respective market requirement. Justification for post submission / approval regulatory queries. - Line extensions, or innovations and...
-
Welfare Officer
5 months ago
Gautam Budh Nagar, India BALAJI PLACEMENT CONSULTANT Full timeWELFARE OFFICER (Female only) Qualification - MSW Manufacturing Plant Location - Ecotech II, Greater Noida - Health & Safety - Staff welfare - Labour Social welfare - Women Safety - Sexual Harassment issues - Child Labour **BALAJI PLACEMENT CONSULTANT,** 21, 4th Floor, K B Complex, Alpha -II, Gr Noida **Salary**: ₹20,000.00 - ₹30,000.00 per...
-
Pharmacist
2 months ago
Kalyan Nagar, Bengaluru, Karnataka, India Motherhood Hospitals Full time**DUTIES AND RESPONSIBILITIES** - Liaising with doctors, nurses and other health care professionals to ensure the safe, effective and economic delivery of drug treatment - Participate in the work of the dispensary, including clinical and accuracy checking of prescriptions and dispensed medicines. - Ensure all work completed complies with Medicines Ethics and...
-
Associate Teacher
5 months ago
Kalyan Nagar, Bengaluru, Karnataka, India THE VEDAM SCHOOL, SASI GROUP OF INSTITUTIONS Full timeAssign associate teacher commitments to share the functions of the instructor and teaching faculty - Assist teachers in implementing curriculum and teaching course material - Focus on providing positive learning and guidelines to students - Interact and communicate with parents about their children’s academic advancement - Develop a positive learning...
-
Staff Nurse
1 month ago
Rajguru Nagar, Ludhiana, Punjab, India RB Luxe Plastic surgery & medispa Full timeJob Title: Staff Nurse Location: Ludhiana, Punjab **Salary**: Competitive; commensurate with experience Qualification: Diploma or Degree in Nursing from a recognized institution; valid registration with the Nursing Council of India To assess the needs of the patients in the ward and make nursing care plan for all patients consulting with treating...
-
Principal Programmer
1 month ago
Nagar, India Medtek.AI Full timeWhy Choose Us ? We have talented professional staff experts in clinical research, medical writing, IT services, data science, and software development. Our professionals are experts in keeping your priorities and goals to follow updated business trends. Our expertise drives cost efficiency to our client. We are flexible, innovative, reliable, and passionate....