Job Posting: Associate – Safety Data Management Specialist at Pfizer, Chennai
Summary:
Pfizer, a leading global pharmaceutical company, is seeking a highly motivated and detail-oriented Associate – Safety Data Management Specialist to join our dynamic team in Chennai, India. This role offers an excellent opportunity for B.Pharm, M.Pharm, or Pharm.D graduates with a passion for pharmacovigilance to contribute to patient safety by ensuring the accurate and efficient processing of safety data. If you possess a strong understanding of ICSR case processing, global safety regulations, and thrive in a collaborative environment, we encourage you to apply.
Job Description:
As an Associate – Safety Data Management Specialist, you will play a crucial role in the pharmacovigilance process, ensuring the integrity and compliance of safety data. You will be responsible for processing individual case safety reports (ICSRs), contributing to the overall safety profile of our products, and ultimately, safeguarding patient well-being.
Key Responsibilities:
- Case Processing and Documentation: Perform comprehensive case processing and meticulous documentation of safety data, adhering to established procedures and guidelines.
- Data Review and Verification: Review, rank, verify, and process case-related information, ensuring accuracy, completeness, and consistency.
- Case Assessment: Assess the validity, seriousness, and timelines of reported adverse events, escalating critical information as necessary.
- Narrative Drafting and Follow-Up: Draft and edit clear and concise case narratives, summarizing key information related to adverse events. Proactively follow up on incomplete information to ensure comprehensive data collection.
- Collaboration and Reconciliation: Collaborate effectively with global safety teams and key partners to reconcile safety data and resolve discrepancies.
- Knowledge Management: Maintain an up-to-date understanding of ICSR guidelines, Standard Operating Procedures (SOPs), and relevant regulatory standards, including global pharmacovigilance regulations.
- Compliance and Adherence: Ensure strict compliance with Pfizer’s internal policies and procedures, as well as all applicable global pharmacovigilance regulations.
- Meeting Participation: Participate in local and international safety review meetings, contributing to discussions and providing valuable insights.
Qualifications:
- Education: Mandatory: Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), or Doctor of Pharmacy (Pharm.D) degree.
- Experience: Minimum 1-2 years of experience in pharmacovigilance or drug safety is required.
- Skills:
- Solid understanding of ICSR processing, including data entry, coding, and assessment.
- Strong analytical and problem-solving skills to effectively evaluate safety data.
- Excellent documentation skills, with a keen attention to detail.
- Ability to work collaboratively and effectively in a team environment, communicating clearly and professionally.
- Proficiency in computer applications, including database management and Microsoft Office Suite.
Preferred Qualifications:
- Hands-on experience with the ARGUS Safety Database or similar pharmacovigilance databases.
- Familiarity with E2B (R2/R3) XML source document processing.
- Proficiency in medical terminology and a strong understanding of regulatory compliance standards in pharmacovigilance.
Job Location & Type:
- Location: Chennai, India
- Work Type: Full-time (Hybrid work model)
- Organization: Pfizer
Compensation:
The salary range for this position is competitive and will be commensurate with experience and qualifications, typically ranging from ₹4,00,000 to ₹6,50,000 per annum. In addition to a competitive salary, Pfizer offers a comprehensive benefits package.
How to Apply:
If you are a qualified and passionate individual seeking a rewarding career in pharmacovigilance, we encourage you to apply! Please submit your application through the Pfizer careers website. We look forward to hearing from you.