Pivot Path is inviting applications for the position of XEVMPD/PSMF Pharmacovigilance Specialist in Bangalore, India. This is an excellent opportunity for experienced pharmacovigilance professionals with expertise in Pharmacovigilance System Master File (PSMF), XEVMPD submissions, aggregate report writing, and ICSR management.

Candidates with 3 to 7 years of pharmacovigilance experience and a strong understanding of EU GVP guidelines, EudraVigilance requirements, EMA, and MHRA safety databases are encouraged to apply.

Job Details

• Position: XEVMPD/PSMF (PV) Specialist
• Company: Pivot Path
• Location: Bangalore, Karnataka, India
• Employment Type: Full-Time
• Experience Required: 3-7 Years
• Industry: Pharmacovigilance, Drug Safety, Regulatory Affairs

Key Responsibilities

Pharmacovigilance System Master File (PSMF) Management

• Develop, review, and maintain Pharmacovigilance System Master Files (PSMFs) in accordance with global pharmacovigilance regulations.
• Collaborate with cross-functional teams to collect and consolidate information required for PSMF updates.
• Ensure continuous maintenance and regulatory compliance of the pharmacovigilance system.
• Implement updates based on evolving pharmacovigilance regulations and industry best practices.

XEVMPD Filings and Compliance

• Prepare and submit accurate and timely Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) filings.
• Coordinate with Regulatory Affairs and Drug Safety teams to ensure medicinal product data accuracy.
• Monitor changes in European pharmacovigilance regulations and maintain ongoing compliance.

Aggregate Report Writing

• Author and review:
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
• Analyze safety data and present scientifically sound conclusions.
• Support signal detection, benefit-risk evaluation, and risk management activities.

ICSR Download and Safety Data Management

• Download and manage Individual Case Safety Reports (ICSRs) from EMA and MHRA databases.
• Distribute safety cases to relevant pharmacovigilance teams.
• Perform initial quality checks to ensure completeness, consistency, and accuracy of safety data.

Qualifications Required

Candidates applying for this Pharmacovigilance Specialist job in Bangalore should possess:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, or a related field.
• Proven experience in:
  • Pharmacovigilance System Master File (PSMF)
  • XEVMPD submissions
  • Aggregate report writing
  • ICSR processing and management
• Strong knowledge of:
  • EU Pharmacovigilance Regulations
  • Good Pharmacovigilance Practices (GVP)
  • EudraVigilance requirements
  • EMA and MHRA safety databases
• Excellent analytical, scientific writing, and communication skills.
• Strong attention to detail and ability to manage multiple deadlines.

Why Join Pivot Path?

Joining Pivot Path provides an opportunity to:

• Work on global pharmacovigilance and regulatory projects.
• Gain exposure to EU pharmacovigilance systems and compliance activities.
• Collaborate with experienced drug safety and regulatory professionals.
• Build expertise in PSMF authoring, XEVMPD submissions, and aggregate report writing.
• Advance your career in pharmacovigilance operations and regulatory affairs.

How to Apply

Interested candidates can share their updated resume at:

Email: devakiran.koppula@pivotpath.com

Candidates with experience in PSMF authoring, XEVMPD filings, PSURs, PADERs, EMA, MHRA databases, and ICSR management are highly encouraged to apply at the earliest.