Executive - Pharmacovigilance

Mega We Care; Thane; On-site; INR 400,000 - 600,000; Full time

Job summary

A leading healthcare company is looking for an Executive - Pharmacovigilance to manage safety reports in a fast-paced environment. The ideal candidate will have a Bachelor's or Master's degree in Pharmacy and 2-4 years of experience in pharmacovigilance, focusing on authoring aggregate reports and ensuring compliance with regulatory standards. Strong attention to detail, exceptional communication, and collaboration skills are essential for this role. If interested, please apply with your details.

Qualifications

• Minimum 2 - 4 years of experience in pharmacovigilance, focusing on aggregate reports.
• Hands-on experience in ICSR case processing and safety signal identification.
• Familiarity with ICH, GVP, FDA, EMA, and local PV regulations.

Responsibilities

• Author aggregate safety reports including PSURs, PBRERs, RMPs, and AddCos.
• Manage data entry and ICSR case processing.
• Conduct literature searches for safety reports.

Skills

ICSR case processing

Literature review

Authoring safety reports

Strong attention to detail

Communication skills

Education

Bachelor’s Degree or Master’s Degree in Pharmacy

Job description

Executive - Pharmacovigilance

Mega Lifesciences is looking for an Executive - Pharmacovigilance to work closely with Assistant Manager - Pharmacovigilance in a fast-paced environment that will offer ample opportunities to learn and expand your experience and expertise.

Job Summary

As an Executive/Sr. Executive – Pharmacovigilance, your key tasks are as below:

• Authoring aggregate safety reports including PSURs, PBRERs, RMPs, and AddCos
• Performing data entry and management of ICSR case processing, literature review, safety signal identification
• Conducting literature searches for individual and periodic safety reports
• Ensuring compliance with internal SOPs and global regulatory requirements
• Coordinating with global pharmacovigilance affiliates

Qualification & Experience

Applications are invited from the potential candidates who meet the following criteria:

• Bachelor’s Degree or Master’s Degree in Pharmacy
• Minimum 2 - 4 years of experience in pharmacovigilance, with a strong focus on authoring aggregate reports (PSUR, PBRER, RMP, AddCo)
• Hands‑on experience in ICSR case processing, literature review, safety signal identification
• Familiarity with regulatory requirements and compliance standards (ICH, GVP, FDA, EMA, local PV regulations)

Skill & Knowledge

The ideal candidate must have hands‑on experience in ICSR case processing, literature search, and authoring or supporting aggregate reports (PSURs, PBRERs, RMPs, AddCos). The incumbent must possess strong knowledge of global pharmacovigilance regulations, coupled with exceptional attention to detail and proficiency in scientific writing. The role requires the ability to prioritize and manage multiple deliverables within committed timelines, along with strong communication, problem‑solving, and collaboration skills—particularly in working with global affiliates and cross‑functional teams.

If you are eager to make the most of this opportunity, kindly fill in the details in respective fields and submit your application for the position.

For any further clarification and information related to the position, you may please contact [phone] (Ms. Pradnya).