Senior PV Operations Specialist

remote zest jobs; India; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Competitive benefits package

Job summary

Safety & Pharmacovigilance Group in India seeks a Senior Pharmacovigilance Operations Specialist to manage drug safety case processing and submissions for global regulatory authorities. You will lead PV vendor activities, ensure compliance, and coordinate cross-functional efforts across GPS to maintain inspection readiness.

The role requires extensive pharmacovigilance experience, knowledge of international regulations, and strong data management skills in a fast-paced environment.

Qualifications

• Bachelor's degree in nursing, pharmacy, or related health care field.
• Minimum 5 years of experience in pharmacovigilance operations.
• Minimum 4 years in end-to-end ICSR case processing (internal or PV vendor).
• Experience with Argus Safety databases and electronic document management systems.
• Knowledge of GCPs, GVPs, FDA/EMA/ICH guidelines and international regulations.
• Proficiency in MedDRA and WHO Drug dictionaries.

Responsibilities

• Responsible for operational activities of ICSR processing by PV vendor.
• Oversee day-to-day ICSR operations, training and compliance of PV vendor.
• Ensure submission compliance of ICSS to global authorities and partners.
• Coordinate data reconciliation of safety databases for Serious Adverse Events.
• Utilize metrics to measure productivity and process improvements.
• Collaborate with GPS colleagues to ensure PV compliance and inspection readiness.
• Support data readiness for regulatory submissions and aggregate reports.

Skills

Pharmacovigilance

ICSR processing

Regulatory compliance

Education

Bachelor's degree in nursing, pharmacy, or health care field

Tools

Argus Safety

Job description

About the position

The reputed company mission of the reputed company Safety & Pharmacovigilance group is to ensure patient safety for reputed company patients receiving reputed company manufactured products. This is done by ensuring that the safety profile of reputed company products remains accurate and up to date throughout the product life cycle of development and through the following reputed company activities:

Relevant safety information including reports of reputed company effects is collected and analyzed.

Possible safety signals are carefully validated and characterized.

Strategies are implemented to minimize risks and to ensure that products are used in a way that maximizes benefits and minimizes risks. Key among these is to ensure that accurate and up-to-date information on the safety profile of reputed company products is available to patients and prescribers in a reputed company manner. Communication with patients, providers, regulatory agencies, and other concerned bodies is essential to this effort. This includes developing and updating the investigator brochure, and protocols as reputed company as any adjunct information for patients and health professionals. This information must be kept reputed company throughout the life cycle of reputed company product.

Reporting to the Vice President, PV Operations and Compliance, Senior Pharmacovigilance Operations Specialist will be responsible for the managing drug safety case management vendor, safety submission execution and compliance, and cross functional collaboration to support risk management and pharmacovigilance activities for the Global Patient Safety department.

Responsibilities

• Responsible for operational activities of ICSS processed by PV case processing vendor.
• reputed company day-to-day ICSR operational activities, processes, training and compliance of PV case processing vendor.
• Ensure reputed company submission compliance of ICSS to global regulatory authorities, business partners, CROs and other parties.
• reputed company reputed company of ICSR regulatory submissions to ensure compliance with global regulations.
• Ensure data reconciliation of the safety and reputed company databases for Serious Adverse Events.
• Effectively utilize metrics to assess productivity, opportunities for workflow and reputed company improvement, and to measure effectiveness of change initiatives.
• Work with VP, PV Operations and Compliance, and other GPS colleagues to ensure PV compliance and inspection readiness.
• Support data readiness for reputed company and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings).
• Collaborate with PV and other functionals to coordinate case management, aggregate reporting, and signal detection activities.
• Collaborate with the preparation of and updates to safety-reputed company study documents (e.g., Safety Management Plans, Reconciliation activities, Database lock activities, etc.)
• Work with VP, PV Operations and Compliance, reputed company Assurance team to ensure PV compliance and inspection readiness.
• Additional safety reputed company duties assigned.

Requirements

• Minimum of bachelors degree in nursing, pharmacy, or other health care reputed company profession.
• Minimum 5 years of experience in pharmacovigilance operations
• Minimum 4 years of experience in managing end-to-end ICSR case processing activities either internally or through PV vendor(s)
• Experience with Argus safety databases, reputed company systems, and electronic document management systems.
• Knowledge of GCPs, GVPs, FDA, EMA, ICH guidelines, and international regulations.
• Proficiency in MedDRA and WHO Drug dictionaries.
• Ability to reputed company in a fast-paced, start-up environment and manage multiple priorities.

Benefits

• In reputed company, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.