Job Title: Senior Pharmacovigilance Reporting Associate
Location: India – Chennai, Trivandrum, Bangalore (Remote/Office with Flex)
Department: Pharmacovigilance
Reports To: Senior Manager / PV Lead
Employment Type: Full-Time
Job Requisition ID: JR133444
Educational Qualification:
Bachelor’s degree in Life Sciences, Pharmacy, or related field (Advanced degree preferred)
Ensure accurate and timely reporting of safety data for pharmaceutical products, supporting pharmacovigilance processes and regulatory compliance while collaborating with cross-functional teams.
Safety Data Reporting:
Prepare and submit adverse event reports and safety data in accordance with regulatory requirements and internal policies.
Review and analyze safety data with clinical and regulatory teams, identifying trends and potential safety signals.
Assist in preparing periodic safety update reports (PSURs), annual reports, and other regulatory documents.
Monitor timelines for safety report submissions and manage any delays or issues proactively.
Data Management & Quality:
Maintain and update pharmacovigilance databases, ensuring data integrity and quality through careful data entry and validation.
Provide training and support to junior team members on reporting procedures and PV regulations.
Compliance & Audits:
Engage in audits and inspections by regulatory authorities, ensuring readiness and adherence to pharmacovigilance reporting requirements.
Stay informed about changes in regulatory guidelines and industry standards to maintain compliance and best practices.
Extensive experience in pharmacovigilance or drug safety reporting.
Strong understanding of pharmacovigilance regulations and guidelines.
Proven ability to prepare and submit accurate adverse event reports timely.
Strong analytical skills to interpret safety data and identify trends.
Excellent communication and interpersonal skills for cross-functional collaboration.
Proficiency in pharmacovigilance databases, reporting tools, and Microsoft Office Suite.
Ability to manage multiple priorities in a fast-paced environment with attention to detail.
Commitment to confidentiality and proper handling of sensitive patient information.
Advanced degree in Life Sciences, Pharmacy, or related field.
Experience with global pharmacovigilance regulations and reporting standards.
Competitive salary and comprehensive benefits, including health insurance, retirement planning, and flexible leave policies.
Global Employee Assistance Programme (TELUS Health) offering 24/7 access to support.
Life assurance and flexible country-specific benefits (childcare vouchers, gym memberships, travel subsidies, etc.).
Inclusive, diverse, and accessible work environment fostering growth and high performance.
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