"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya"

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"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya." (Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers) Introduction If you are a fresher or early-career professional aiming to build a strong career in Medical Device Regulatory Affairs and Quality Assurance , this opportunity can be a perfect starting point. ELEXES Medical Consulting Pvt. Ltd. has announced hiring for the position of Project Associate I – Regulatory Affairs & Quality Assurance (RA/QA) . This role is specially designed for fresh graduates and candidates with up to 6 months of experience who want hands-on exposure to global medical device regulations , including US FDA, EU MDR, CDSCO, Health Canada , along with ISO 13485 quality systems . The position offers real project experience under expert mentorship, making it ideal for long-term growth in the medical device regulatory domain. About The Company – ELEXES Medical Consulting Pvt. Ltd. EL...

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“Pharmacovigilance Jobs in India 2025 | Executive/Sr. Executive at Mega Lifesciences, Thane”

"Career Opportunity: Executive/Sr. Executive – Pharmacovigilance at Mega Lifesciences (Apply Now)"



(Pharmacovigilance Jobs in India 2025)

Are you a pharmacy or life science professional looking to build a strong career in pharmacovigilance? Here is a great opportunity to join Mega Lifesciences, a global pharmaceutical and wellness company known for its high-quality healthcare products and strong commitment to patient safety. Mega Lifesciences is currently hiring for the role of Executive/Sr. Executive – Pharmacovigilance for its Thane location in India.

This position is ideal for candidates who want to grow in the field of drug safety, aggregate report authoring, ICSR case processing, and global pharmacovigilance operations. If you're aiming to develop advanced PV skills and work in a globally compliant environment, this role could be a perfect next step.


About Mega Lifesciences:-

Mega Lifesciences is an international pharmaceutical company with operations across Asia, Africa, Latin America, Australia, and Europe. Known for its science-based products and strong regulatory adherence, the company has built a powerful reputation in the global healthcare industry. Its diverse portfolio includes nutraceuticals, prescription medicines, OTC solutions, and wellness products.

With a firm commitment to patient safety, Mega Lifesciences continuously invests in strengthening its global pharmacovigilance infrastructure. Working here means exposure to diverse regulatory markets, including EMA, FDA, MHRA, TGA, and other international health authorities.


Role Overview: Executive/Sr. Executive – Pharmacovigilance:-

The Executive/Sr. Executive – Pharmacovigilance will handle both operational and analytical responsibilities related to drug safety. This includes aggregate report preparation, safety data assessment, regulatory reporting, and communication with international PV teams.

This role provides excellent exposure for candidates who want to grow in corporate pharmacovigilance and learn end-to-end global safety processes.


Key Responsibilities:-

As part of the pharmacovigilance team at Mega Lifesciences, your major responsibilities include:

1. Aggregate Report Authoring

You will prepare, review, andfinalisee the following key safety documents:

  • PSURs (Periodic Safety Update Reports)

  • PBRERs (Periodic Benefit-Risk Evaluation Reports)

  • RMPs (Risk Management Plans)

  • AddCos (Addendum to Clinical Overviews)

These reports are critical for evaluating the benefit–risk profile of the product as per global regulatory standards.

2. ICSR Case Processing

  • Conduct data entry of Individual Case Safety Reports (ICSRs) into the global safety database.

  • Ensure cases meet regulatory timelines such as EMA 15-day, FDA 7-day, and local reporting requirements.

  • Perform medical coding using MedDRA terminology.

  • Review completeness and accuracy of patient, event, and product details.

3. Literature Search & Monitoring

  • Perform regular literature searches to identify published safety information.

  • Document and report relevant literature cases as per SOPs and compliance requirements.

4. Global PV Compliance

  • Ensure compliance with ICH, GVP Modules, EMA, FDA, and other global guidelines.

  • Maintain documentation according to regulatory standards and internal SOPs.

5. Cross-Functional Collaboration

  • Coordinate with international pharmacovigilance affiliates.

  • Work with regulatory affairs, medical affairs, clinical teams, and global safety units.

6. Signal Detection & Safety Surveillance (Additional Advantage)

Candidates with experience in preliminary signal detection or trend analysis will have an added advantage.


Required Qualifications & Experience:-

To be eligible for this role, candidates must meet the following criteria:

  • Education:

    • B.Pharm or M.Pharm (mandatory for preference)

  • Experience:

    • 2–4 years of relevant experience in Pharmacovigilance

  • Skill Requirements:

    • Strong experience in aggregate safety report authoring

    • Hands-on knowledge in ICSR processing

    • Understanding of global PV guidelines and compliance

    • Good scientific writing and documentation skills

    • Ability to work with safety databases and MedDRA coding

    • Excellent communication and analytical skills

This role demands attention to detail, accuracy, and a proactive mindset to manage safety data effectively.


Why Join Mega Lifesciences?

1. Global Exposure

Work with international teams and gain experience in stringent regulatory environments like EMA, FDA, and MHRA.

2. Growth Opportunities

The company supports continuous professional development through internal training, skill enhancement, and leadership exposure.

3. Supportive Workplace Culture

Mega Lifesciences is known for its inclusive, collaborative, and innovation-driven work environment.

4. Learn Cutting-Edge PV Practices

From aggregate reports to global safety data management, you’ll gain experience across key pharmacovigilance domains.


Job Location:-

Thane, Maharashtra, India

This is a full-time, office-based role located at the company’s India operations hub.


How to Apply:-

If you’re ready to advance your pharmacovigilance career, apply through the official link below:

👉 Apply Here – Executive/Sr. Executive Pharmacovigilance at Mega Lifesciences

(Insert your actual link here when publishing on the blog.)

For any queries or collaboration, you may also reach out:

📧 Gmail: pharmaduniya38@gmai.com

  • Pharmacovigilance jobs in India

  • Mega Lifesciences hiring

  • Drug safety jobs in India

  • PV executive jobs 2025

  • PSUR PBRER jobs

  • Pharma jobs in Mumbai

  • ICSR case processing jobs

  • Pharma Duniya jobs


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