Safety Officer (Spv)
Share
Job Location:
Monthly Salary:
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Use Your Power for Purpose
At Pfizer our purpose is clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
As Safety Officer you play a critical role in safeguarding patient safety by ensuring robust pharmacovigilance systems highquality safety data and full regulatory compliance. Through scientific rigor sound judgment and collaboration with internal and external stakeholders you help ensure that the benefitrisk profile of Pfizer products is continuously monitored understood and appropriately managed to protect patients and public health.
What You Will Achieve
In this role you will:
Lead and actively perform local pharmacovigilance activities including adverse event monitoring safety reporting risk management local safety oversight inspection preparedness and countryspecific safety obligations.
Review analyze prepare and complete safetyrelated reports to support accurate assessment of product safety profiles and compliance with regulatory requirements.
Carry out endtoend case management activities ensuring the accuracy consistency completeness and timeliness of individual case safety reports (ICSRs) including special and complex scenarios.
Ensure compliance with regulatory timelines for expedited reporting and timely contribution to aggregate safety reports and other regulatory deliverables.
Act when delegated and required by local regulations as Deputy Local QPPV or local pharmacovigilance responsible/contact person supporting continuity of regulatory accountability.
Provide subject matter expertise to internal teams suppliers and stakeholders on safetyrelated issues and liaise with key partners on safety data collection reconciliation and handling.
Mentor and support colleagues by sharing pharmacovigilance expertise overseeing case handling quality and contributing to team capability development.
Apply regulatory requirements Pfizer policies SOPs and writing practices consistently while identifying risks monitoring performance and implementing corrective actions where needed.
What You Bring
Minimum Requirements
Health Care Professional background or equivalent relevant experience
Minimum 4 years of experience in pharmacovigilance data management clinical care or clinical/scientific research
Strong knowledge of pharmacovigilance principles medical terminology and global as well as local safety regulations
Proven organizational timemanagement and problemsolving skills to meet strict regulatory timelines
Ability to work independently exercise sound judgment and resolve both routine and complex safety issues
Fluency in spoken and written English
Bonus Points If You Have
Experience in medical or regulatory writing
Demonstrated leadership or mentoring experience within safety teams
Strong stakeholder engagement and negotiation skills as a safety subject matter expert
Advanced familiarity with safety databases data extraction and analysis tools
Experience supporting inspections audits or regulatory interactions related to pharmacovigilance
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
MedicalRequired Experience:
Unclear Seniority
Key Skills
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
