Senior PV Officer

STADA; Reading; Hybrid; GBP 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company seeks a Senior Pharmacovigilance Officer to ensure compliance with regulations and act as the deputy Local Pharmacovigilance Officer. Key responsibilities include managing regulatory activities and mentoring team members. The ideal candidate will possess exceptional communication skills and experience in the pharmaceutical sector. A competitive salary and employee benefits, including a hybrid working model and health support, are offered.

Benefits

Competitive salary and annual bonus scheme

Hybrid working model

25 days annual leave plus bank holidays

Health benefits including Private Medical Insurance

Employee Assistance Programme

Qualifications

• Established PV professional with proven experience in pharmaceuticals or biotechnology.
• Ability to work effectively with cross-functional teams.
• Experience in compliance with MHRA/EU PV regulations.

Responsibilities

• Serve as a key liaison for MHRA and STADA PV matters.
• Develop and update company SOPs to align with regulatory requirements.
• Manage regulatory activities, including Periodic Safety Update Reports.
• Mentor and train team members while ensuring compliance.

Skills

Multi-channel communication skills

Organisational abilities

Interpersonal skills

Problem-solving approach

Attention to detail

Proficiency in MS Office

Job description

As a Senior Pharmacovigilance (PV) Officer, you will play a pivotal role in ensuring compliance with MHRA/EU regulations, directives, and guidelines. You will act as the deputy Local Pharmacovigilance Officer (LPO), supporting the UK point of contact for MHRA and group PV matters. This role is integral to maintaining the highest standards of pharmacovigilance and contributing to the safety and efficacy of our products.

Responsibilities

• Serve as a key liaison for MHRA and STADA PV matters, ensuring updates to the PV System Master File and Quarterly Reports.
• Develop and update company Standard Operating Procedures (SOPs) to align with regulatory requirements.
• Support business continuity and crisis management initiatives.
• Manage regulatory activities, including Periodic Safety Update Reports, Safety Variations, Risk Management Materials, and labelling steering committees.
• Play a critical role in audits, inspections, and self-inspection activities, maintaining risk trackers and compliance metrics.
• Collaborate with cross-functional teams, including participation in STADA weekly meetings and scientific committees.
• Oversee PV agreements, change controls, software validation, and database user acceptance testing.
• Mentor and train team members while ensuring compliance with MHRA/EU PV regulations and internal standards.

Qualifications

• We are seeking an established PV professional with proven experience in the pharmaceutical or biotechnology industry. The ideal candidate will have:
• Exceptional multi-channel communication skills adaptable to all levels of internal and external stakeholders.
• Strong organisational and multi-tasking abilities.
• Excellent interpersonal skills and the ability to work effectively with cross-functional teams.
• A proactive problem-solving approach and the ability to work under pressure and on their own initiative.
• High attention to detail and accuracy.
• Proficiency in MS Office and other relevant software tools.

At STADA we pursue our purpose "Caring for people's health as a trusted partner" worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

Britannia Pharmaceuticals, part of the STADA Arzneimittel AG group of companies, is a UK based pharmaceutical company specialising in the neurology market. Britannia focuses on innovative products for chronic and serious medical conditions, and in particular, the treatment of Parkinson's disease. We are highly committed to improving the quality of life for People with Parkinson's disease.

STADA Group values and promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology, or sexual orientation. We use the strength of our uniqueness to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation, and the promotion of an inclusive working environment.

We would be pleased to get to know you. Please use our online job portal to submit your application: https://jobs.stada.com

Company Values

• Entrepreneurship: Driving new ideas and creating future growth and value.
• Agility: Leading change with flexibility and decisiveness.
• One STADA: Acting in the best interests of the company as a whole.

Core Competencies

• Personal Excellence: Producing high-quality work and adapting to changing priorities.
• Delivering Results: Taking ownership of your work and ensuring accuracy.
• Relationship Building & Communication: Actively listening, interpreting messages, and seeking clarity when needed.
• Driving Change & Innovation: Proactively seeking improvements and successfully implementing changes.

How we care for you At Britannia Pharmecuticals Lts our purpose "Caring for people's health as a trusted partner" motivates us every day. And what would be a better place than starting with our own colleagues. Which is why we give much in return: Competitive salary and annual bonus scheme. Salary Sacrifice Pension Scheme offering 6% employer contribution rates. Hybrid working - we spend three days in the office (Monday, Tuesday, Thursday), with the remaining days working at home (Wednesday & Friday). 25 days of annual leave plus bank holidays with the potential to buy up to 5 additional days. Health benefits including Private Medical Insurance. Free winter flu jab. Wellbeing support through our Employee Assistance Programme and KYAN Wellbeing - offering free coaching and counselling services for you and your family. Electric Car Scheme through Octopus Energy. Cycle to Work Scheme. Enhanced Family Leave. Plus, many more employee benefits & celebration events.