Logo for ICONMA

Senior Pharmacovigilance (PV) Clinical Scientist

ICONMA

Role overview

Qualifications

  • Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD)
  • Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities
  • Writing experience in science/medical writing
  • Strong project management skills

Responsibilities

  • Completes drug safety monitoring and tracking in accordance with pharmacovigilance standards
  • Reviews, evaluates, and verifies potential AE information to determine required actions
  • Responsible for maintaining thorough knowledge of ICSR requirements for assigned Therapeutic Areas
  • Collaborate with departments and partners on drug safety data exchange

Key facts

Hard skills

Pharmacovigilance Data Entry Project Management Quality Assessment Adverse Event Monitoring Health Administration Customer Complaint Resolution Medical Writing Project Collaboration

Other skills

  • Training And Development
  • Leadership
  • Communication
  • Decision Making
  • Detail Oriented
  • Problem Solving

About the company

ICONMA logo

ICONMA

Management Consulting

We provide Professional Staffing Services & Project-Based Solutions for a broad range of Fortune 500 organizations. ICONMA is a certified Woman-Owned staffing company and was founded in 2000. ICONMA’s corporate headquarters is in Troy, Michigan, and has 15+ locations worldwide. What makes ICONMA stand out in a fiercely competitive industry? *We provide integrated, full lifecycle services across a broad range of business and technical platforms. *No single company can duplicate our full range of staffing and permanent recruiting services nationwide. *Proven track record of attracting and retaining exceedingly skilled professional workers in a highly competitive market. SERVICES OFFERED Staff Augmentation (Contract, Contract to Hire, Direct Hire, Single Source) Data Analysis Project-Based Services & Solutions Hire Train Deploy Service Model Offshore Staff Augmentation Payroll Services AREAS OF EXPERTISE - Information Technology - Engineering - Business Professional - Accounting/Finance - Admin/Clerical/Call Center - Healthcare/Clinical/Scientific - Marketing/Creative mail linkedin@iconma.com Phone (888) 451-2519 Website http://www.iconma.com

Company details

Company typeLarge
IndustryManagement Consulting
Company size1001 - 5000

Links

Website LinkedIn See all jobs

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job description

Our Client, a Biotech company, is looking for a Senior Pharmacovigilance (PV) Clinical Scientist for their Remote location.
 
Responsibilities:
  • Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and client Standard Operating Procedures (SOPs) ○ Reviews, evaluates, and verifies potential AE information during triage to determine required action per internal policies and procedures and perform data entry of adverse events by timely completion of the case via Roche global safety database. Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessment
  • Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
  • Responsible for leading efforts to ensure quality of Individual Case Safety Reports (ICSRs) is at par with company standards
  • Responsible for maintaining thorough knowledge of ICSR requirements for assigned Therapeutic Areas (TA)
  • Performs trend analysis of vendor case processing issues for assigned TA and escalates to vendor, TA Leads and USPS management as applicable
  • Update and create SOPs; lead process improvement initiatives
  • Responsible for developing executive summary on the quality trends observed on a quarterly basis
  • Ensures quality of Health Authority (HA) submissions is at par with local regulations
  • Responsible for Clinical Review of cases processed in-house and by vendors
  • Understands case processing data to evaluate error rates and potential compliance impact
  • Responsible for training internal USPS and/or vendors staff or team and ensure PV compliance
  • Collaborate with departments and partners on drug safety data exchange
  • Responsible for ensuring appropriate data correction in the safety database for identified issues or errors
  • Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Compliance Team Scientist /Vendor staff via the correspondence module
  • Accountable for training internal and external staff members on using correspondence module ○ Performs reconciliation of outgoing communications
  • Maintains robust knowledge of Technical Product Complaints (TPC) & Medical Product Complaint (MPC) for all company products including combination products
  • Responsible for ensuring all product complaints are reported to the appropriate stakeholders within defined timelines
  • Ensures appropriate due diligence to obtain missing and/or additional information for Adverse Events (AEs) is performed in accordance with company SOPs / local and global regulations
  • Escalates any issues pertaining to follow up activities and provide strategic resolution to USPS management
  • Assists USPS management in maintaining oversight for GVP vendors
  • Identifies the risks and gaps pertaining to case processing for GVP Vendors
  • Continuously monitors feedback to inform quality improvements and updates
  • Responsible for performing impact assessment for any new / updated company SOPs or Health Authority requirements pertaining to ICSR processing and implements any process changes required based on the identified impact
  • Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
  • Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
  • Acts as single point of contact with key stakeholders for safety-related activities, identifies potential business gaps, and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Patient Safety PV Clinical management
  • Responsible for the preparation and development of Patient Safety presentations and participates in the education offer internal /external stakeholders/vendors as applicable
  • Acts as Subject Matter Expert (SME) for safety-related activities within Global Safety Database per client SOPs
  • Provide support during audits and inspections
  • Collaborates with other patient safety teams as needed
 
Requirements:
  • Demonstrates capability to comprehend medical information
  • Demonstrates ownership, initiative and accountability
  • Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility
  • Demonstrates strong, dynamic leadership skills
  • Works well independent or within teams and is effective in collaborating with others internally and externally Ability to exercise independent judgment and discretion in matters of significance
  • Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
  • Ability to flex and thrive in an agile and fast-changing environment
  • Strong attention-to-detail
  • Strong attention-to-detail in establishing priorities and meeting deadlines
  • Strong project management skills
  • Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD)
  • Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities (Preferred); OR equivalent clinical experience with thorough understanding of FDA safety regulations, ICH guidelines, and other applicable regulatory guidance documents, global PV regulatory environment, EMA regulations (Required)
  • Writing experience; science/medical writing (Required)
  • Computer proficiency and Data entry experience (Required)
  • Project Management (Required)
  • Senior Pharmacovigilance Clinical Scientist role requiring 5 to 7 years of experience.
 
Why Should You Apply?

Apply once. Then go straight to the hiring manager.

After you apply, unlock the direct contact details of the people who actually make the call. A quick follow-up makes you 5x more likely to land an interview.

MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
Unlocked after you apply
·

Related jobs

California (USA)

Other jobs at ICONMA

Premium

Reach out to the hiring manager directly.

Gain access to the contact details of the hiring managers who actually decide, and reach out to network with them directly. That, plus more when you upgrade:

  • Full match report with fit score and gaps
  • Career diagnostics on how recruiters read you
  • Curated company matches and warm intros
  • 48h early access to new roles

Cancel anytime.