Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowFirst seen 5 days ago

Senior Specialist, Global ICSR Management

Lifelancer3,750 open roles

Where
Remote
Work mode
Remote
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSenior Specialist, Global ICSR ManagementLifelancer · Remote

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Lifelancer's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

The posting

Job Title: Senior Specialist, Global ICSR Management

Job Location: Brazil Remote

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement: Fluent English is Required

Preferred Experience: Pharmaceutical/Biotech Industry

Location: Brazil Remote

General Description:

The Senior Specialist, Global ICSR Management independently executes the triage of individual case safety reports (ICSRs) to ensure initial assessment of cases is in line with processes and regulations.

The Senior Specialist, Global ICSR Management independently executes the case processing and quality control of individual case safety reports (ICSRs) to ensure completeness, accuracy, and quality standards are met for submissions to regulatory authorities and other stakeholders.

The Senior Specialist performs SAE reconciliation between the safety and clinical databases.

The Senior Specialist is responsible for performing tasks in adherence to internal and external timelines and meeting quality, compliance and productivity target metrics, support decision making and provide training.

Essential Functions:

ICSR Case Management Activities:

Upon successful completion of the core ICSR case management curriculum and targeted training for Triage and Case processing tasks under a mentor's supervision, team members will independently manage the tasks. After achieving the required baseline quality results, the Senior Specialist will be eligible to handle all the workflows (Triage, Case processing, QC) based on case workload and business need from all sources (e.g. clinical trials, post-market spontaneous and solicited sources, literature, etc.) to ensure completeness, accuracy, and quality standards are met for submissions to regulatory authorities and other stakeholders.

SAE Reconciliation:

  • Perform SAE reconciliation between safety and clinical databases.
  • Track SAE reconciliation to ensure completion and adherence to internal and external timelines and resolve or escalate issues with SAE reconciliation.

Quality and Compliance Indicators:

Meet quality/compliance KPI or metrics.

Productivity and Process Excellence:

  • Meet productivity/volume KPI or metrics.
  • Demonstrate problem solving capabilities and execute continuous improvement opportunities within ICSR management.

Decision Making:

  • Make process decisions consistent with operational policies, SOPs and WIs.

Vendor/CRO Management:

  • Execute ICSR related activities as described in PV Agreements/Contracts following instruction.

Training & Onboarding:

  • Deliver training to new team members.
  • Develop and update training materials.
  • Provide feedback to line manager for review about new team member onboarding status.
  • Support resolving issues or escalate to line manager for new team members.

Minimum Requirements – Education and Experience:

  • Minimum bachelor’s degree (major in life sciences, clinical medicine, nursing, pharmacy), or other health care professional or the equivalent combination of relevant education or professional experience.
  • Advanced degree preferred Global Patient Safety

Other Experience:

  • Minimum 2 years' experience in drug safety/pharmacovigilance or relevant clinical experience, including training required.
  • Understanding of Global regulatory requirements (i.e. ICH, GVP, FDA 21CFR312.32, 314.80, GCP, NMPA Announcement (No. 66, 2018), PAL of PRC (Dec 2019)) for capture and submissions of pharmacovigilance individual case safety reports to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities/national competent authorities.
  • Understanding of databases, case processing activities, including data acquisition/intake, triage, coding, narrative construction and due diligence activities.
  • Excellent communication skills (verbal and writing).
  • Strong problem-solving skills.
  • Effective time management skills.
  • Results oriented and strong attention to detail.

Supervisory Responsibilities: N/A

Travel: N/A

Computer Skills:

Argus safety database and other platforms required, MS Office suite, Excel, PowerPoint, Visio, digital skills are preferred.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Lifelancer's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Lifelancer's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Lifelancer's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.