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    • Support regulatory inspections, audits, and CAPA management.
    • Coordinate the preparation, review, and submission of PSURs, RMPs and ACOs in accordance with…
    • Managing projects within regulatory department.
    • Follow up on technical-regulatory and scientific issues.
    • Provide responses to regulatory questions relating to…
    • Proven experience in Scientific or Medical Affairs within the medical device industry, ideally with a focus on surgical devices.
    • Partake in, and manage, regulatory compliance activities, including the preparation and submission of regulatory filings, as appropriate, reports and…
    • Policy Stakeholder Engagement - Drive the development of government affairs strategies, supporting local teams in compliantly engaging policy stakeholders…
    • Strong governance, compliance, and risk management expertise within a global regulatory environment.
    • Complex Problem Solving: Resolve highly ambiguous…
    • Strong governance, compliance, and risk management expertise within a global regulatory environment.
    • Complex Problem Solving: Resolve highly ambiguous…
    • Providing expert GVP and PV legislation guidance across the organisation, and ensuring that regulatory changes translate into timely, concrete action.
    • Relevant certifications in clinical research, medical affairs, or pharmaceutical medicine (e.g., FFPM, Board Certification, or equivalent) strongly preferred.
  • View similar jobs with this employer
    • You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain…
    • Maintain and develop full regulatory compliance for medical device manufacturing under ISO 13485 and MHRA guidelines.
    • Co-ordinate, lead and develop the team of internationally based regulatory consultants engaged in global notification services (ca. 10 - 15 staff).
    • Experience producing medical device risk analysis.
    • Support device classification and regulatory strategy activities.
    • Hours: *Full time, 37.5 hours per week.
  • View similar jobs with this employer
    • Prior industry experience in medical devices is strongly preferred.
    • The Cardiovascular Program Specialist (CVPS) will provide expert clinical support, education…
    • Working familiarity with labelling-related audits and the regulatory frameworks that govern labelling compliance.

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Job Post Details

Senior Pharmacovigilance Officer - job post

Milpharm Ltd
Uxbridge UB11 1AF
£28,000 - £35,000 a year - Permanent, Full-time

Job details

Pay

  • £28,000 - £35,000 a year

Job type

  • Permanent
  • Full-time

Location

Uxbridge UB11 1AF

Benefits

Pulled from the full job description

  • Sick pay
  • Life insurance
  • Company pension
  • Company events
  • On-site parking

Full job description

  • Support the UK RPP in maintaining an effective pharmacovigilance system in compliance with MHRA requirements.
  • Assist in ensuring continuous oversight of all PV activities performed internally and by third parties.
  • Support regulatory inspections, audits, and CAPA management.
  • Contribute to PV governance activities and safety compliance monitoring.
  • Provide oversight of Medical Information activities to ensure compliance with pharmacovigilance obligations.
  • Ensure product complaints, adverse events, special situations, and safety information received through Medical Information are appropriately identified, processed, and reported.
  • Support and perform reconciliation activities between Medical Information and other stakeholders
  • Ensure deviation, CAPA, change control, and risk management processes.
  • Drive inspection readiness activities across the PV system.
  • Deliver pharmacovigilance training to internal stakeholders
  • Coordinate the preparation, review, and submission of PSURs, RMPs and ACOs in accordance with regulatory requirements.
  • Preparation and implementation and maintenance of approved RMM programmes.
  • Coordinate the preparation, review, UK PSMF and all associated annexes.
  • Ensure the PSMF accurately reflects the current pharmacovigilance system and organisational structure.
  • Oversight and management of safety variations

Qualification:

  • Essential Degree in Life Sciences, Pharmacy, Nursing, Medicine, or related healthcare discipline.
  • Significant pharmacovigilance experience within the pharmaceutical industry.
  • Strong knowledge of UK Pharmacovigilance legislation and MHRA GVP requirements.

Job Types: Permanent, Full-time

Pay: £28,000.00-£35,000.00 per year

Benefits:

  • Company events
  • Company pension
  • Life insurance
  • On-site parking
  • Sick pay

Ability to commute/relocate:

  • Uxbridge UB11 1AF: reliably commute or plan to relocate before starting work (required)

Education:

  • Bachelor's (required)

Licence/Certification:

  • UK Work Authorisation (required)

Work Location: In person

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