Regulatory affair Work, Jobs in Brampton, Cam (with Salaries)

Pharmacovigilance Licensing Manager
Sobi —Cambridge
- Full-time
- Remote
- English
- Bachelor's degree
- Organisational skills
Quick apply
Registration Executive
ABAgri —Peterborough
- Monday to Friday
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Global Medical Advisor - Anti-Infectives
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- ICU experience
- Communication skills
Medical Affairs Scientist
OGT —Cambridge
- Laboratory experience
- Bachelor's degree
- Organisational skills
- Employee discount
Quick apply
Global Medical Advisor - Rescue Treatments
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Communication skills
14d
Senior QA Auditor - 60% - 80%
Healx —Cambridge
- Part-time
- Hybrid work
- Analysis skills
- Bachelor's degree
- Travel
- Annual leave
- Work from home
Quick apply
Regulatory Affairs Systems and Data Manager
Mundipharma —Cambridge
- Full-time
- Hybrid work
- Communication skills
Senior Manager, Market Access Specialty Care
Sobi —Cambridge
- Full-time
- Remote
- Doctoral degree
- English
- Master's degree
Quick apply
Medical Director, Medical Safety
Jazz Pharmaceuticals —Cambridge
- £113,600 - £170,400 a year
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
Senior Regulatory Affairs Director
AstraZeneca —Cambridge
- Presentation skills
- Organisational skills
- Leadership
3d
(Senior) Global Medical Director, Established Brands
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Leadership
Associate Director, Regulatory Legal Counsel
Illumina —Cambridge
- £110,600 - £166,000 a year
- Full-time
- Management
- English
- Travel
Clinical Site Manager
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Management
- Machine learning
- Organisational skills
- Annual leave
- Life insurance
Quick apply
SPARK Trainee- UK
MoonLake Immunotherapeutics —Cambridge
- Hybrid work
- English
- In-person
- Communication skills
Quick apply
Senior Clinical Site Manager
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Management
- Laboratory experience
- Machine learning
- Annual leave
- Life insurance
Quick apply
Medical Director, UK and Ireland
Mundipharma —Cambridge
- Full-time
- English
- Leadership
General Counsel & Company Secretary (0.8FTE)
Qureight Ltd —Cambridge
- Part-time
- Hybrid work
- Machine learning
- Negotiation
- Annual leave
- Life insurance
Quick apply
8d
Director, Clinical Safety Scientist (Radiopharmaceuticals)
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- Leadership
- Communication skills
- Annual leave
- Employee assistance programme
Quick apply
Senior Director, Business Development
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Excel
- English
- Annual leave
- Life insurance
Quick apply
Global Marketing Associate Director – Breast Cancer (12 months FTC – Maternity Cover)
AstraZeneca —Cambridge
- Management
- Sales
- Bachelor's degree
6d

I want to receive the latest job alerts for regulatory affair in brampton, cam

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Pharmacovigilance Licensing Manager

Sobi -
Cambridge

Quick apply

Job details

Full-time

Qualifications

English
Quality assurance
Bachelor's degree
Organisational skills
Communication skills

Full job description

Company Description

Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and specialty care. With our head office in Stockholm, Sweden, Sobi also has premises in Basel, Switzerland. You can find more information about Sobi at www.sobi.com.

We are seeking a dynamic and experienced Senior Pharmacovigilance Agreements Manager to join our team. As a key member of our Global Pharmacovigilance Agreements (PVA) team, you will play a crucial role in managing strategic collaborations and alliances to ensure the highest standards of patient safety and regulatory compliance.

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

Bachelor's 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.

Quick apply

Refine Your Search

regulatory affair jobs in brampton, cam

Pharmacovigilance Licensing Manager

Registration Executive

Global Medical Advisor - Anti-Infectives

Medical Affairs Scientist

Global Medical Advisor - Rescue Treatments

Senior QA Auditor - 60% - 80%

Regulatory Affairs Systems and Data Manager

Senior Manager, Market Access Specialty Care

Medical Director, Medical Safety

Senior Regulatory Affairs Director

(Senior) Global Medical Director, Established Brands

Associate Director, Regulatory Legal Counsel

Clinical Site Manager

SPARK Trainee- UK

Senior Clinical Site Manager

Medical Director, UK and Ireland

General Counsel & Company Secretary (0.8FTE)

Director, Clinical Safety Scientist (Radiopharmaceuticals)

Senior Director, Business Development

Global Marketing Associate Director – Breast Cancer (12 months FTC – Maternity Cover)

I want to receive the latest job alerts for regulatory affair in brampton, cam

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected