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Pfizer

Safety Officer (Spv)

Posted 18 Hours Ago
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Hybrid
DKI Jakarta
Mid level
Hybrid
DKI Jakarta
Mid level
As a Safety Officer, you lead pharmacovigilance activities, ensure compliance with safety regulations, manage adverse event reporting, and provide expertise on safety issues while mentoring colleagues.
The summary above was generated by AI
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, high‑quality safety data, and full regulatory compliance. Through scientific rigor, sound judgment, and collaboration with internal and external stakeholders, you help ensure that the benefit-risk 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 country‑specific safety obligations.
  • Review, analyze, prepare, and complete safety‑related reports to support accurate assessment of product safety profiles and compliance with regulatory requirements.
  • Carry out end‑to‑end 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 safety‑related 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, time‑management, and problem‑solving 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.
Medical

Top Skills

Analysis Tools
Data Extraction
Pharmacovigilance Systems
Safety Databases

Pfizer Chennai, Tamil Nadu, IND Office

Chennai, India

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