IQVIA Career Opportunity: Join as PV Safety Aggregate Report Specialist-I – Elevate Your Impact in Healthcare

0
179
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

Welcome to a career opportunity that merges expertise with impact! IQVIA is thrilled to extend an invitation for talented professionals to join our team as PV Safety Aggregate Report Specialist-I. As a pivotal player in the field, IQVIA is at the forefront of driving innovation and excellence in pharmacovigilance.

PV Safety Aggregate Report Specialist-I

If you are a dedicated individual with a passion for ensuring drug safety and a keen eye for detail, this role as PV Safety Aggregate Report Specialist-I is tailor-made for you. Join us in shaping the future of healthcare by contributing to the safety assessment and reporting processes.

Position: PV Safety Aggregate Report Specialist-I

Job Overview
Serve as principal owner of the SARA deliverable and have a responsibility to complete the deliverable in compliance with all applicable service level agreements.

Essential Functions
1. Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.
2. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings
3. Author. Responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
4. Act as literature lead, backup lead, and reviewer/QCers to contribute to conducting ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests, and aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines.
5. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities per agreed signalling strategies, perform signal validation and evaluation analyses for proactive and timely identification of signals and characterization of risks. Participate as a core member and present in safety management teams. Responsible for full documentation and tracking of movements.
6. In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
7. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
8. Participate in internal and external audits and inspections, as required.
9. Contribute to achieving departmental goals, e.g. utilization realization and productivity metrics.
10. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all the essential training is executed promptly to maintain compliance and documentation.
11. Serve as the interface between the global project lead and the working team.
12. Conduct regular lessons learned with the operational teams to ensure all information from the customer is cascaded to the relevant team members.
13. Provide mentorship and training to less experienced resources.
14. Provide regular reports to the overall project manager and department management on project metrics, statement of work (SOW) changes, and client requests or concerns.
15. Participate in Project review meetings with management.
16. Communicate and document project issues to project team members and department management promptly.
17. Support and/or contribute to technology/innovation activities.

Qualifications
1. Bachelor’s Degree Bachelor’s Degree Req
2. 4+ years of relevant experience in drug safety, aggregate reporting, signal management, or literature surveillance. Pref
3. Equivalent combination of education, training and experience. Req
4. Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate
5. Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate
6. Good knowledge of medical terminology. Intermediate
7. Strong organizational skills and time management skills. Intermediate
8. Strong verbal/written communication skills. Intermediate
9. Self-motivated and flexible. Intermediate
10. Excellent attention to detail and accuracy. Intermediate
11. Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate
12. Proven ability to multi-task and manage competing priorities and deadlines. Intermediate
13. Willingness and aptitude for learning new skills across all Lifecycle Safety service lines. Intermediate

How to Apply
Interested may reach us at pavan.cm@iqvia.com

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

Walk-in Interview as Project Technical Support-III at ICMR – National Institute of Nutrition in Hyderabad More Info..
Recruitment of Pharmacist/Pharmacist Grade II/Pharma Chemist/Chemical Examiner/Dispensing Attendant (100 Posts) at AIIMS More Info..
Applications are invited for the Post of Scientific Officer (09 Post) Under GPSC More Info..
Opportunity as a Consultant Scientific & Project Research Scientist under ITRC-ICMR More Info..
Recruitment of Assistant Professor (Biotechnology) at NIPER Guwahati – Apply Now More Info..
Opportunity for B. Pharma/ M. Pharma Freshers as Regulatory Affairs Intern Trainee at Genedrift – WFH Job More Info..
Applications are invited for Senior Research Fellow at Punjab University, Chandigarh More Info..
AstraZeneca is hiring Regulatory Affairs Manager – Apply Now More Info..
Fortera is hiring Safety Science Analyst – Apply Now More Info..
Recruitment of Project Assistant at Regional Centre of Biotechnology – 27th November 2023 More Info..
Vacancy for Project Technical Support-III at Department of Pharmaceutical Engineering & Technology, IIT-BHU, Varanasi
More Info..
Recruitment of Pharmacist (05 Post) under Directorate General of Health Services More Info..
Recruitment of Junior Research Fellow at National Institute of Technology Rourkela – Apply Now More Info..
Walk-in Interview for B. Pharma/ M. Pharma in Quality Control Department at Intas Pharmaceuticals – 17th November 2023 More Info..
Recruitment of Drug Sampler at Central Drugs Standard Control Organization (CDSCO) – Apply Now More Info..
Opportunity for B. Pharma Candidates as Clinical Trial Coordinator at IPGMER Kolkata – Apply Now More Info..
Recruitment of Jr. Pharmacist (02 Post) at Central Medical Services Society under BECIL – Apply Now More Info..
Vacancy of Associate Consultant at BIRAC (Biotechnology Industry Research Assistance Council)- Apply Now More Info..
Recruitment of Pharmacist under Directorate of Medical & Hearth services, Dadra & Nagar Haveli More Info..
Recruitment of Pharmacist (02 Post) at Urban Primary Health Center – Apply Now More Info..
Vacancy of Pharmacist (09 Post) under Zilla Swasthya Samiti – Apply Now More Info..
Jubilant Generics Limited is Hiring B. Pharma/M. Pharma/B. Sc. Lifescience Candidates as Executive/Sr. Executive – Pharmacovigilance
More Info..
Walk-in Interview for B.Sc./ B. Pharm/ B. Tech/ M. Sc./ M. Pharm for Production Department at MSN Laboratories Pvt. Ltd. More Info..
Recruitment of Technical Assistant/ Documentation Assistant at Regional Centre for Biotechnology – B. Pharma/ BE/ B. Tech/ B. Sc can apply
More Info..
Career Opportunity as Project Scientific Assistants at Tata Institute of Fundamental Research – B. Pharma/ B. Sc/ BV Sc. can apply More Info..
Recruitment of Assistant Professor/ Associate Professor (07 Posts) at AKTU, Lucknow -Apply Now More Info..
Opportunity for B. Pharma/ M. Pharma as Regulatory Affairs Associate at Teva Pharmaceuticals More Info..
Parexel is hiring Pharma Candidates as Principal Medical Writer – Apply Now More Info..
Macleods Pharmaceuticals is hiring M. Pharma/ M. Sc. candidates as Quality control officer for QC department – Apply Now More Info..
Opportunity for Pharma Candidates as Junior Research Fellow at MNNIT, Allahabad – Apply Now More Info..
Recruitment of Junior Research Fellow at Panjab University, Chandigarh – Apply Now More Info..
Applications are invited for Pharmacist Post at Health Medical & Family Welfare Department More Info..
Vacancy for Pharma Candidates for R & D Department at Patanjali Research Foundation – Apply Now More Info..
Vacancy for Laboratory Technician (Pharmacy) under Kerala PSC – Apply Now More Info..
Recruitment of Pharmacist (02 Post) under Kerala PSC – 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