Talent.com
Sobi
Pharmacovigilance Licensing ManagerSobi • Cambridge, England, UK
Pharmacovigilance Licensing Manager

Pharmacovigilance Licensing Manager

Sobi • Cambridge, England, UK
30+ days ago
Job type
  • Full-time
Job description

Key Responsibilities:

  • Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs) including development execution maintenance and termination where applicable along with all associated deliverables. Contribute to strategy setting in collaboration with line management as required ensuring compliant and efficient solutions for all parties.
  • Collaborate with global functions to provide expert advice and support on commercial agreements named patient use supplies and other managed access programs ensuring optimal and compliant pharmacovigilance obligations are embedded.
  • Work closely with internal Patient Safety functions and cross-functional Sobi departments to ensure full alignment with Global Pharmacovigilance (GPV) agreements.
  • Oversee and manage pharmacovigilance collaborations and alliances with external business partners including co-marketing co-development distributor partners and healthcare organizations.
  • Lead the negotiation and establishment of pharmacovigilance agreements clearly defining roles responsibilities and conditions to enable seamless collaboration.
  • Partner efficiently with the Sobi Global Pharmacovigilance group and other key stakeholders to ensure PVAs are effectively implemented maintained and monitored.
  • Provide subject matter expertise on current and evolving pharmacovigilance regulations and guidelines both internally and externally.
  • Support pharmacovigilance audits and inspections related to collaborations including contribution to corrective and preventive action (CAPA) plans.
  • Train and educate internal teams on pharmacovigilance standards procedures and collaboration requirements.
  • Continuously identify opportunities for process improvement efficiency gains and risk mitigation across pharmacovigilance collaborations.

Qualifications :

  • Bachelors degree preferably in Life Sciences or relevant scientific disciplinee.
  • Minimum of 3 years of experience in the pharmaceutical industry with solid experience in pharmacovigilance regulatory affairs and or quality assurance with a focus on safety alliance or collaboration management.
  • At least 2-3 years of specific experience in managing patient safety alliances or partnership
  • Strong understanding of global and local pharmacovigilance regulations and guidelines.
  • Excellent negotiation communication and problem-solving skills. Able to drive towards solutions and reach common grounds.
  • Proven ability to work effectively in cross-functional and international teams.
  • Strong organizational skills with the ability to manage multiple projects motivated and driven - able to take ownership of a complex agreement process and drive it through to finalisation in agreed timeframes.
  • Proficiency in written and spoken English; knowledge of other languages is advantageous.


Additional Information :

If you are a motivated professional with a passion for patient safety collaboration and regulatory compliance we invite you to join our Global PV team develop and maintain our PV system to deliver our portfolio of product for rare disease to patients across the globe and make a significant impact in our organisation. Apply now and help us shape the future of patient safety through strategic alliances and partnerships.

To apply please submit your resume and a cover letter detailing your relevant experience and accomplishments.


Remote Work :

Yes


Employment Type :

Full-time


Experience: years
Vacancy: 1
Create a job alert for this search

Pharmacovigilance Licensing Manager • Cambridge, England, UK

Similar jobs

Pharma Learning Strategy Lead - High-Impact Solutions

Syneos HealthCambridge, England, GB
Full-time

Syneos Health in Cambridge seeks a Senior Learning Strategy Consultant to partner with pharmaceutical customers, leading design alignment and execution of high-impact learning solutions.You will bl... Show more

 • Promoted

Chief Pharmacist & Medicines Optimization Leader

jobs pharmaguidelinesCambridgeshire and Peterborough, England, GB
Full-time

A leading NHS Trust is looking for an experienced Chief Pharmacist to lead pharmacy services and ensure compliance with statutory responsibilities.The successful candidate will possess outstanding ... Show more

 • Promoted

Pharma Regulatory Affairs Manager - Hybrid (UK)

PE GlobalCambridge, England, GB
Temporary

PE Global is seeking a Regulatory Affairs Manager for a 12-month contract in Cambridge.This hybrid role requires only one office visit per month.Key responsibilities include managing regulatory sub... Show more

 • Promoted

Contract Manager

AWD OnlineCambridge, ENG, GB
Full-time +2

An excellent opportunity for an experienced contract and supplier management professional to manage ICT suppliers, commercial performance, service delivery, risk and continuous improvement within a... Show more

 • Promoted

Driving Instructor (Driving Licence Required)

My Four WheelsWisbech, Norfolk, UK
Full-time +1

Become a Driving Instructor – Nationwide | Earn Up to £50,000+ with My Four Wheels.Looking for a new career with flexibility, independence and great earning potential? My Four Wheels is a&#160... Show more

 • Promoted

Compliance Quality Engineer – Medical Devices

Cpl Life SciencesCambridge, England, GB
Full-time

A leading pharmaceutical research firm is seeking a Quality Engineer – Compliance for a 12-month hybrid contract in the Cambridge area.You will lead design control and risk management activities re... Show more

 • Promoted

Compliance Officer

Taylor & Francis GroupMilton, England, GB
Full-time

Informa is a leading academic publishing, business intelligence, knowledge and events business, creating unique content and connectivity for customers all over the world.It is listed on the London ... Show more

 • Promoted

Director Pharmacovigilance & Drug Safety

MoonLake Immunotherapeutics (NASDAQ: MLTX)Cambridge, England, GB
Full-time

Director Pharmacovigilance & Drug Safety.Director Pharmacovigilance & Drug Safety.MoonLake Immunotherapeutics (NASDAQ: MLTX).Director Pharmacovigilance & Drug Safety.Be among the first 25 applicant... Show more

 • Promoted

Senior Compliance & Risk Lead — AML, Sanctions, Hybrid

BWF LegalCambridgeshire and Peterborough, England, GB
Full-time

BWF Legal is seeking a Compliance Officer / Risk & Compliance Manager to lead risk and regulatory compliance across the firm.Working with the COLP and MLRO, you will oversee AML, sanctions, audits,... Show more

 • Promoted

Global CMC Regulatory Consultant - Drug Development Leader

ScendeaBishop's Stortford, England, GB
Full-time

A global regulatory consultancy is looking for a Senior Consultant (CMC) to join their hybrid team.The role involves providing expert CMC development strategies and regulatory advice to clients.Can... Show more

 • Promoted

Regulatory Affairs Manager (IVD)

ArevnaCambridge, England, GB
Full-time

Arevna Cambridge, England, United Kingdom.Regulatory Affairs Manager (IVD).Arevna Cambridge, England, United Kingdom.Be among the first 25 applicants.Direct message the job poster from Arevna.Arevn... Show more

 • Promoted

Regulatory Data & RIM Strategy Lead

Mundipharma Research LimitedCambridge, England, GB
Full-time

Mundipharma Research Limited is seeking a Regulatory Affairs & Systems Data Manager based in Cambridge (Hybrid/Flexible).This role will ensure effective management of all systems and data within re... Show more

 • Promoted

Compliance & Risk Solicitor

Errington LegalBishop's Stortford, England, GB
Permanent

Take the next step in your career with this supportive and highly-regarded Compliance & Risk team.Compliance & RiskSolicitor - Bishop's Stortford with hybrid working.A top regional full-service law... Show more

 • Promoted

Pharmacy Manager - £60,000 A Year

SuperdrugCambridge, United Kingdom Of Great Britain And Northern Ireland, UK
Part-time

Lead the Way in Community Healthcare – Become a Superdrug Pharmacy Manager!.Location: Cambridge Sidney Street (CB2 3HX).Part-time applicants also welcome!.Up to £60,000 FTE – negotiable depending o... Show more

 • Promoted

Global Brand & Reputation Lead — Pharma

Orion PharmaCambridge, England, GB
Full-time

Orion Pharma is seeking a Corporate Brand & Reputation Manager to define and bring our corporate brand to life across key audiences, markets and channels.Based in Reading or remote options across m... Show more

 • Promoted

Relief Clinical Pharmacist – Medicines Optimization Safety

HI HUBCambridge, England, GB
Full-time

A healthcare facility in Cambridge is seeking a Bank Pharmacist to ensure the safe and effective use of medicines.You will interact with consultants, nurses, and patients to assess medication needs... Show more

 • Promoted

Customer Experience & Operations Consultant (Fixed-term contract)

Molton BrownBishop's Stortford, ENG, GB
Temporary

Company description Born on South Molton Street, London in 1971, Molton Brown is an icon of uniquely British style.Today, Molton Brown is one of the leading global brands in Kao's global cosmet... Show more

 • Promoted

Regulatory Affairs Systems and Data Manager

Mundipharma InternationalCambridge, England, GB
Full-time +1

Regulatory Affairs Systems and Data Manager page is loaded## Regulatory Affairs Systems and Data Managerlocations: GB Cambridgetime type: Full timeposted on: Posted 30+ Days Agojob requisitio... Show more

 • Promoted

Pharmacy Manager | Outpatients | Cambridge - £65,000 - £70,000 A Year

Compass AssociatesCambridge, United Kingdom Of Great Britain And Northern Ireland, UK
Full-time

Pharmacy Manager – Outpatients – Cambridge.Position offered by Compass Associates.Your actual pay will be based on your skills and experience – discuss with recruiter.Career progression and develop... Show more

 • Promoted

Recruitment Partner (Freelance / Remote)

RecXchangeBishop's Stortford, England, United Kingdom
Remote
Full-time

Recruitment Partner (Freelance / Remote).Independent / Flexible / Commission-Based.RecXchange is a global recruiter operating system designed for experienced recruiters and ambitious professionals ... Show more