Work Opportunity as a Senior Drug Safety Associate at Avance Clinical – Apply Now

0
152
WhatsApp D. Pharma Group Join Now
Telegram D. Pharma Group Join Now
Telegram Group Latest Pharma Jobs Join Now
Telegram B. Pharma Group Join Now
Telegram Medicine Update Group Join Now
WhatsApp B. Pharma/ GPAT Channel Join Now

Avance Clinical, a well-known clinical research company, is thrilled to share that a Senior Drug Safety Associate position is open. This might be the best option for you if you’re an experienced professional looking for a fast-paced work atmosphere and an opportunity to help shape the future of clinical research!

Senior Drug Safety Associate

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

Role Title: Senior Drug Safety Associate
Location: Bengaluru

Qualifications, Skills and Experience
1. Ordinary Degree in an appropriate/related discipline.
2. Minimum of 8 years’ experience in a safety/pharmacovigilance role or relevant combination of pharmaceutical/CRO industry experience and qualifications.
3. Minimum of 8-10 years’ experience in pharmaceutical industry/CRO working in a GCP environment.
4. Formal and current ICH GCP training.
5. Thorough knowledge of Australian regulatory and EC Clinical trial safety reporting requirements.
6. Sound knowledge of FDA and EMA regulatory and EC Clinical trial safety reporting requirements
7. Sound knowledge of MedDRA and WHO Drug coding.
8. Ability to communicate at a high level with clients, senior management and other stakeholders.

Why should you join Avance Clinical?
1. We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.
2. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

Broad Purpose
The Senior Drug Safety Specialist is responsible for the provision of Drug Safety reporting and management services for assigned projects, ensuring the preparation (or review) of Safety Reporting Plans (SRP), the collection, processing and reporting of safety events and other safety information in accordance with the Clinical Study Protocol (CSP), Avance (or sponsor) Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.

Core Responsibilities
1. Configuration of study specific safety databases in accordance with Avance SOPs.
2. Maintain a project specific safety database/dataset (where Avance Clinical holds the safety database).
3. Create, modify and/or review study specific SRPs as required per project in accordance with the CSP and Client/Avance Clinical contractual arrangements.
4. Prepare ICSR reporting forms and completion guidelines for the Investigational Sites and liaise with the CPMs and CRAs to ensure timely distribution of the approved forms and guidelines to the sites
5. Participate in Study “Kick-Off” meetings with study project staff as required.
6. Autonomously act as Lead Safety Officer and maintain oversight on regulatory compliance and status of safety-related services for assigned projects.
7. ICSR processing – Ensure timely reporting, tracking, filing and distribution of SAE, EIU, SUSAR, and/or other safety reports (as required) to applicable parties including Regulatory Authorities (RAs), Ethics Committees (ECs), Sponsors/Clients and Investigators.
8. Perform reconciliation of SAE receipt and Regulatory reporting with Sponsors/Clients as outlined in the Study Specific SRP.
9. Liaise with Data Management (DM) for reconciliation of information provided on SAE reports with the study Adverse Event database and entering of single cases into the SAE and EIU Database where applicable.
10. Ensure up-to-date knowledge of applicable regulatory safety requirements associated with relevant countries as required on a per project basis.

What we offer
1. Stimulating work
2. Project diversity
3. An intellectual challenge
4. An agile & flexible workplace
5. Opportunity to progress
6. Stability
7. Sense of community
8. A leadership team that are working together on a common goal
9. Flexible work options
10. Great tools / tech to do your job
11. A competitive salary & an extra days holiday for your birthday!

What next?
As a growing business we’re looking for likeminded people to join us – we hope that’s you.
To join our team please submit your CV & cover letter as one Microsoft Word document
You must have full Australian / US / Indian working rights to be considered

Alternatively, you could e mail your CV to ramya.yadehalli@avancecro.com

At Avance difference is encouraged, its celebrated and it’s something we strive for. We empower cultural, disability, LGBTI+, and gender equality.

<<<<<<<<<<<<<MORE JOBS>>>>>>>>>>>>>>>>

Walk-In Interview for QA/ QC Department at Glenmark Pharmaceuticals – 17th December 2023 More Info..
Walk-in Interview as a Trainee at Macleods Pharma – Freshers can Apply More Info..
Applications are Invited for the Post of Pharmacist (05 Vacancy) at Rajawadi Hospital – Apply Now More Info..
Opportunity as a Pharmacist/ Pharmacy Assistant (60 Post) under Department of Skill Development & Training AP – Apply Now More Info..
Applications are Invited for Research Associateship at CSIR-National Chemical Laboratory More Info..
Applications are Invited for Junior Research fellow (JRF) at Central University of Rajasthan – Apply Now More Info..
Walk-in Interview as a Assistant Manager/ Sr. Executive/ Executive for various Departments at PMBI More Info..
Research Opportunity as a Junior Research Fellow (JRF) at NIPER Hajipur More Info..
Applications are Invited for the Post of Professor/ Ass. Professor at NIPER Hajipur – Apply Now More Info..
Work Opportunity as a Field Monitor at Translational Health Science and Technology Institute (THISTI) More Info..
Opportunity as a Technical Supervisor Gr. II/ Scientist Gr. II at NIPER SAS Nagar – Apply Now More Info..
Recruitment of Professor/ Associate Professor (04 Post) at Guru Jambheshwar University of Science and Technology (GJUST) – Apply Now More Info..
Career in Clinical Research: Walk-in Interview for Clinical Research Associates at Aizant Drug Research Solution Pvt. Ltd. More Info..
Unlock Your Career Potential as a Project Manager at Syngene More Info..
Walk-In Interview for Multiple Position at Torrent Pharmaceuticals – 17 December 2023 More Info..
Opportunity as a Senior Research Fellow (SRF) at ICMR-National Institute for Research in Reproductive & Child Health More Info..
Recruitment of Pharmacist (19 Post) under Kolkata City NUHM Society – Apply Now More Info..
Walk-In Interview as a Field Assistant at CSIR-National Botanical Research Institute (CSIR-NBRI) More Info..
Work Opportunity as a Medical Writer I at Parexel – Apply Now More Info..
Research Opportunity as a Senior Research fellow (SRF) at Regional Ayurveda Research Institute – Apply Now More Info..
Opportunity as a Formulation Development Executive and Jr. Production Executive at KAPL – Freshers can Apply More Info..
Career Opportunity as a Medical Writer at Macleods Pharmaceuticals – Freshers can Apply More Info..
Recruitment of Pharmacist at Rajiv Gandhi Cancer Institute & Research Centre (RGCIRC) – New Delhi More Info..
Research Opportunity as a Junior Research Fellow (JRF) – DBT Funded Project at NIMHANS More Info..
Walk-in Interview as a Registrar at Assam Pharmacy Council  More Info..
Opportunity as a Project Associate-II at ICMR-National Centre for Disease Informatics and Research More Info..
Walk-in Interview as a Pharmacist (16 Post) at Ex-Servicemen Contributory Health Scheme (ECHS) Polyclinics More Info..
Walk-In Interview as a Production/ QA/ QC Officer at Glenmark Pharmaceuticals – 17th December 2023 More Info..
Career Opportunity as a Junior Research Fellow (JRF) at IISER Bhopal More Info..
Pharmacist (04 Post) recruitment under National Health Mission (NHM), Wayanad More Info..
Recruitment of Pharmacist (09 Post) at District Health Society under NHM More Info..
Work Opportunity as a Quality Assurance Officer at Avantor – Apply Now More Info..
Career Opportunity as a CDSCO Medical Device Specialist at JR Compliance More Info..
Recruitment of Pharmacist (09) under NHM Scheme at Ayush Division More Info..
Vacancy of Pharmacist (05) at Zilla Panchyath Hassan – Apply Now More Info..
Recruitment of Pharmacist at ECHS Polyclinics – Walk-in Interview More Info..
Vacancy of Pharmacist at Ex-Servicemen Contributory Health Scheme (ECHS) More Info..
Career Opportunity as a Research Officer at ICMR-NARI – Apply Now More Info..
Recruitment of Pharmacists (09 Posts) at Govt. Medical College & Govt. General Hospital More Info..
Join Us as a Research Associate – Ignite Your Research Journey with AIIMS Delhi More Info..
Work Opportunity as a Regulatory Affairs Officer at Coral Drugs Pvt. Ltd. – Apply Now More Info..
Career Opportunity as a Medical Affair-Medical Writer at Eli Lilly – Apply Now More Info..
Opportunity as a Scientific Writer at Sanofi Global Hub – Apply Now More Info..
Recruitment of Medical Content Writer at Manipal Hospital – Apply Now More Info..
Career Opportunity as a Quality Assurance/ Quality Control Trainee at Simson Pharma Ltd – Apply Now More Info..
Opportunity as a Medical Writer at Novo Nordisk – Apply Now More Info..
Career Opportunity as a Junior Regulatory Affairs Associate at Parexel – Apply Now More Info..
Work Opportunity as a Clinical Data Coder for B. Pharma/ M. Pharma freshers at IQVIA More Info..
Opportunity as a Senior Research Fellow (SRF) at Regional Ayurveda Research Institute – Walk-in Interview More Info..
Applications are invited as Pharmacist Grade-I at SVNIRTAR – Apply Now More Info..
Applications are invited for Junior Research Fellow (JRF) at Institute of Chemical Technology (ICT) Mumbai More Info..
Walk-in Interview as a Pharmacist at Ex-Servicemen Contributory Health Scheme (ECHS) More Info..
Recruitment of Paramedical Staff at Nilachal Seva Pratisthan – Apply Now
More Info..
Recruitment of Pharmacist under Health Medical & Family Welfare Department – Apply Now More Info..

 

<<<<<<<<<<<<<JOIN US>>>>>>>>>>>>>>>>

Subscribe our PHARMACY INDIA Youtube Channel for more Pharma Updates Click Here
Follow us on Instagram Click Here
Download PHARMACY INDIA MOBILE APP from Google Play Store  Click Here
Follow us on LinkedIn Click Here

LEAVE A REPLY

Please enter your comment!
Please enter your name here