This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Pharmacovigilance Specialist based in India.
This role sits at the core of drug safety operations, ensuring the continuous monitoring, assessment, and documentation of adverse events across clinical trials and post-marketing surveillance. You will play a key role in safeguarding patient safety by ensuring accurate case processing, regulatory compliance, and high-quality safety reporting. The position involves close collaboration with cross-functional teams and global stakeholders in a regulated life sciences environment. You will be responsible for evaluating complex safety data, contributing to regulatory submissions, and ensuring adherence to global pharmacovigilance standards. The role also includes peer review, mentoring junior colleagues, and supporting continuous improvement in case processing workflows. It is a highly detail-oriented and impact-driven position where scientific rigor and compliance excellence are essential. You will contribute directly to the safety and lifecycle management of innovative therapies.
Accountabilities:
- Perform end-to-end case processing of adverse events from clinical trials and post-marketing sources, including MedDRA coding, seriousness, and expectedness assessments.
- Conduct case follow-up activities to gather missing or additional safety information and ensure complete and accurate documentation.
- Draft, review, and validate case narratives in compliance with global pharmacovigilance standards and client requirements.
- Ensure timely client and regulatory notifications related to individual case safety reports (ICSRs).
- Perform peer reviews of safety cases to ensure quality, consistency, and regulatory compliance across deliverables.
- Monitor, identify, and escalate discrepancies or safety concerns to senior PV leadership as required.
- Support training initiatives by contributing to materials development and delivering knowledge-sharing sessions.
- Provide oversight and subject matter expertise for pharmacovigilance deliverables, including HCP reviews where applicable.
- Mentor and guide junior team members to support capability development within the PV function.
- Stay updated on global pharmacovigilance regulations, guidelines, and industry best practices.
Requirements:
- Bachelor’s degree in Life Sciences; advanced degree or clinical qualification (RN, RPh, PharmD) preferred.
- Minimum 3 years of experience in pharmacovigilance, drug safety, or related clinical safety operations.
- Strong working knowledge of adverse event case processing, ICSR management, and regulatory reporting requirements.
- Hands-on experience with pharmacovigilance systems such as Oracle Argus Safety, ARISg, or equivalent safety databases.
- Solid understanding of MedDRA coding, seriousness assessment, expectedness evaluation, and case narrative development.
- Strong attention to detail with high standards of accuracy in documentation and data review.
- Excellent communication and interpersonal skills, with the ability to work across global and cross-functional teams.
- Strong organizational and multitasking abilities in a deadline-driven environment.
- Ability to work independently while also contributing effectively in a collaborative team structure.
- Intermediate understanding of project management principles and pharmacovigilance operations.
Benefits:
- Competitive compensation aligned with experience and expertise
- Opportunity to work in a global pharmacovigilance and life sciences environment
- Exposure to end-to-end drug safety operations across clinical and post-marketing programs
- Career development opportunities, including mentorship and leadership exposure
- Collaborative, multicultural work environment with cross-functional engagement
- Continuous learning opportunities in global safety regulations and PV systems
- Flexible working arrangements (remote/hybrid depending on project needs)
- Involvement in high-impact work supporting patient safety and public health.
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