Executive - Risk Management Plan (Pharmacovigilance)

Glenmark Pharmaceuticals; Navi Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Glenmark Pharmaceuticals in Mahape, Navi Mumbai seeks a seasoned professional for the Executive (Aggregate reports and Risk Management). You will author aggregate reports and RMPs, review risk management plans, and respond to regulatory queries for Glenmark products.

Ideal candidate has 3+ years in PV with exposure to EU/US regulations, ICH and GCP guidelines, and a strong understanding of drug development. Collaborative with global teams, audits and CAPA support included.

Qualifications

• Bachelors in Pharmacy and Masters required.
• Total 3+ years of PV experience in risk management plans and aggregate reports.
• Good understanding of drug development process and drug safety regulatory requirements (EU, US, ICH, GCP).

Responsibilities

• Authoring of aggregate reports and risk management plans (RMPs).
• Review of risk management plans.
• Respond to regulatory authority/healthcare professional queries for assigned products.
• Review literature search results for ICSRs and articles for inclusion in safety reports.
• Liaise with GPV functions, international Glenmark affiliates and external partners.
• Support audits, inspections and CAPA related to aggregate reports and RMPs.

Skills

Pharmacovigilance

Risk management

Aggregate reports

Regulatory compliance

Education

Bachelor's in Pharmacy

Master's in Pharmacy

Job description

Executive (Aggregate reports and Risk Management)

Location: Mahape, Navi Mumbai

Education

Bachelors in Pharmacy & Masters

Experience

Total 3+ years of experience in PV especially in Risk Management Plans, and aggregate reports.

Good understanding of drug development process and drug safety regulatory requirements (EU, US regulations as well as ICH and GCP Guidelines).

Summary

The Aggregate report and risk management group within Glenmark Global Pharmacovigilance (GPV) is responsible for the scientific evaluation of safety information and the continuous monitoring of the benefit-risk profile of all Glenmark products throughout all stages of the product lifecycle. The Aggregate report and risk management team works to ensure that Glenmark is compliant with global legislation and guidelines that govern the development, registration and commercialization of its medicines. The Aggregate report and risk management scientist is responsible for preparation of aggregate reports, risk management plan and to keep an oversight on risk minimization activities and risk management plans of Glenmark products.

Responsibility

1. Authoring of aggregate reports and risk management plans (RMPs). Keeping oversight on risk management activities.


2. Review of risk management plans.


3. Respond to regulatory authority/healthcare professionals queries for assigned products.


4. Review literature search results for ICSRs and articles for inclusion in safety reports.


5. Liaise and collaborate with other GPV functions, international Glenmark affiliates and external business partners.


6. Support audits, inspection and CAPA management relating to Aggregate report and risk management plans ensuring audit requests completed on time.


7. Provide technical guidance in the development and maintenance of procedural documentation.


8. Compliance activities for in-house activities.


9. Ensuring CAPA/deviation are completed on time.


10. Maintenance of PSMF data for aggregate and risk management team.