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.

Senior Pharmacovigilance Officer (FTC)

Reading | United Kingdom (GB) | Full-time | Fix-term 

OBJECTIVE

To perform PV activities in line with relevant MHRA/EU regulations, directives and guidelines

KEY ACCOUNTABILITIES

• Acts as deputy Local Pharmacovigilance Officer (LPO) and acts as the deputy UK point of contact regarding MHRA and group (STADA) PV matters, ensuring the completion of the updates to the Pharmacovigilance System Master File and Quarterly Report
• Perform the Business Continuity Test
• Support the business with Crisis Management
• Regulatory Activities (Periodic Safety Update Reports/Safety Variations/Labelling Steering Committee/Risk Management Materials)
• Audits/Inspections (Support internal/external, Self-inspection activities, Maintain risk tracker)
• Participate in meetings (STADA Weekly Meeting (with Director Medical Affairs/Head of PV/Senior Manager Quality Systems/T&R Safety))
• Support the Scientific Committee (from a PV perspective e.g. writing new PV Agreements)
• Review and implementation of Change Controls
• Trending of Corrective and Preventative Actions
• Compliance Metrics (Review & Trending) and performing the Monthly Quality Checklist
• Involvement in product launches (from a PV perspective)
• Point of contact for vendors, including arranging meetings, dealing with/escalating issues
• Training/mentoring of Team Members
• Performing the activities of the PV Officer when resource is limited

PERSONAL SPECIFICATION (Skills required to perform the job)

• Established PV professional with proven leadership experience in pharmaceutical, or biotechnology industry
• Excellent multi-channel communication skills and the ability to adapt these to all levels of internal and external customers
• Exceptional organisational skills
• Good interpersonal skills – ability to work with cross-functional teams
• Computer literate with knowledge of all MS packages
• Accuracy and attention to detail
• Ability to work under pressure
• Ability to work under own initiative – proactive problem-solving approach

We are looking for talents with expert knowledge and an entrepreneurial spirit that enjoy working collaboratively in a global team. We are pleased to get to know you better. Please use our online portal to submit your application: jobs.stada.com