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Pharmacovigilance Safety Risk Lead

Employer
Apex International Recruitment Ltd
Location
Remote working in the UK
Salary
Competitive daily rate of pay
Start date
6 Sep 2022
Closing date
3 Oct 2022

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Job Details

DETAILS:

  • Full-time contract position
  • ASAP start for minimum 12 month contract
  • Work remotely in the UK
  • Competitive hourly rate of pay
  • Global pharma company

 

THE ROLE:

  • The Safety Risk Lead (SRL) will perform proactive Safety Surveillance (SS) and Risk Management with focus on signal detection and evaluation, risk assessment and safety risk minimization

  • Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products
  • Ensures consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WMS/PSSR Authors.
  • Performs ad hoc special scholarly Safety Surveillance & Risk Management activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.
  •  Identifies opportunities for Consistency and Standards for Safety Surveillance & Risk Management approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such.
  •  Innovates, champions and implements novel approaches to Safety Surveillance & Risk Management across BUs: engages in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.
  • Engages in inspection readiness and support. Provision of data to project managers for metrics and activity tracking.
  • Frequently independently performs evaluation of all sources of safety data, identifies and independently analyzes safety signals, and presents evaluation of safety signals and benefit risk assessments to the appropriate forums.
  • Full job description available on application

 

THE CANDIDATE:

  • MD (physician) degree, PharmD (pharmacist) or PhD
  • Minimum 5 years of: medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development experience required.
  •  Experience in post-marketing PV / established products essential.
  • Thorough understanding of Safety Risk Management and signal detection internal and external environment, including applicable regulations and guidances.
  • Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle.
  • Only candidates with existing right to work in the UK/EU will be considered

 

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

Company

Apex are a specialist recruitment agency who supply permanent, contract and interim staff to pharma, biotech and CROs across the UK

Our core specialist fields include:

  • Medical Information / Medical Affairs (including Med Info, Scientific Advisors, Medical Advisors, Final Signatory pharmacists and Medics, MSLs, medical directors)
  • Pharmacovigilance / Drug Safety (including QPPVs)
  • Regulatory Affairs

Other specialist fields we recruit for include:

  • QA & QC (including QPs)
  • Healthcare Compliance
  • Clinical Research (including CTMs/CSMs/CRAs/CTAs, CRPs)
  • Health Economics / Market Access
  • Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers)

We have the ability to recruit for the areas above from junior level through to Director level.

Find Us
Website
Telephone
01227 844466
Location
Clover House
John Wilson Business Park
Whitstable
Kent
CT5 3QZ
GB
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