Pharmacovigilance Manager

Pharmacovigilance Manager - PV Systems & Compliance
Company: Seed Pharma
Location: India
Experience: 7-10 years
Employment Type: Full-time

We are looking for an experienced Pharmacovigilance Manager to take ownership of the overall PV system, compliance and quality oversight for our clients.

About the Role
This is a PV systems and compliance-focused management role. The successful candidate will be responsible for overseeing the end-to-end PV framework, maintaining compliant and effective PV systems, identifying gaps and implementing improvements.

The role will involve working directly with QPPVs and collaborating with regulatory, quality and other internal teams.

Key Responsibilities

PV System Management:
Manage and oversee end-to-end Pharmacovigilance systems assigned by QPPV.
Develop, review and maintain PV SOPs, procedures, work instructions, forms and templates.
Establish and maintain appropriate PV processes and safety responsibilities.
Review PV systems for compliance, effectiveness and continuous improvement.
Maintain appropriate PV documentation and records.

PV Compliance & Quality
Monitor compliance with applicable PV regulations, guidelines and contractual requirements.
Establish and monitor PV quality metrics and compliance indicators.
Identify PV compliance gaps and coordinate appropriate CAPA.
Support and coordinate PV audits, inspections and audit responses.
Conduct PV system assessments and compliance reviews.
Ensure appropriate training and training records are maintained.
PV Agreements & Oversight
Develop, review and maintain PV Agreements, SDEAs and other safety-related agreements.
Define and monitor PV responsibilities between relevant parties.
Provide oversight of third-party vendors and service providers where applicable.
Ensure appropriate reconciliation and oversight activities are implemented.

Safety Operations Oversight
Provide oversight of ICSR management, including intake, assessment, processing, follow-up, QC and regulatory reporting.
Monitor case-processing timelines and quality.
Oversee literature monitoring and other sources of safety information.
Support signal detection and safety evaluation activities.
Provide oversight of aggregate safety reporting, including PBRER/PSUR and DSUR where applicable.
Provide technical guidance and mentoring to PV team members.
Conduct PV training for internal staff and clients where required.
Support development and improvement of the PV function.

Must-Have Skills & Experience
7-10 years of relevant Pharmacovigilance experience with regulated countries EU/TGA.
Strong experience in PV system management and oversight.
Good knowledge of GVP, ICH and applicable Pharmacovigilance regulations.
Excellent documentation and communication skills.
Ability to independently manage multiple clients/projects.
Strong problem-solving and organisational skills.
Experience working with international pharmaceutical companies or CROs.

What We Are Looking For
We are looking for a hands-on PV professional who can take ownership of the overall PV system.
The successful candidate should be able to independently assess a client's PV setup, identify gaps, develop practical solutions, establish appropriate procedures and controls, monitor compliance and communicate effectively with clients.

This is not a case-processing-only position. Candidates whose experience is primarily limited to ICSR processing without broader PV system, compliance or quality experience may not be suitable.

Education
Bachelor's/Master's degree in Pharmacy, Pharmacology, Life Sciences, Medicine or a related discipline.