Macleods Pharmaceutical Hiring for Pharmacovigilance Roles in Mumbai | M.Pharm, B.Pharm, BDS, BHMS Apply Now
Macleods Pharmaceutical Hiring for Pharmacovigilance Roles in Mumbai | Apply Now
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(Macleods Pharmaceutical Hiring for Pharmacovigilance Roles) |
Introduction
Pharmacovigilance continues to be one of the most important functions within the pharmaceutical industry, ensuring patient safety through effective monitoring, reporting, and compliance activities. Professionals with expertise in drug safety, regulatory compliance, safety data management, and pharmacovigilance operations are increasingly in demand across global pharmaceutical organizations.
Macleods Pharmaceutical Ltd has announced multiple openings within its Pharmacovigilance Department at its R&D facility in Andheri, Mumbai. The company is recruiting experienced professionals for Safety Variations, SDEA (Safety Data Exchange Agreements), and Website Review & Compliance Report Activity roles. Candidates possessing relevant qualifications and pharmacovigilance experience can explore this opportunity to advance their careers in drug safety and regulatory compliance.
About Macleods Pharmaceutical Ltd
Macleods Pharmaceuticals Ltd is one of India's leading pharmaceutical companies with a strong presence in domestic and international markets. Established in 1986, the company has expanded its operations across numerous therapeutic segments and exports pharmaceutical products to more than 140 countries worldwide.
The company is headquartered in Mumbai, Maharashtra, India, and employs thousands of professionals across manufacturing, research and development, quality assurance, regulatory affairs, pharmacovigilance, and commercial operations. Macleods is recognized for its commitment to innovation, quality standards, and global regulatory compliance.
Through continuous investments in research, manufacturing excellence, and patient safety initiatives, Macleods has established itself as a respected name in the pharmaceutical industry.
Job Overview Summary
Macleods Pharmaceutical Ltd is inviting applications from experienced pharmacovigilance professionals for multiple positions at its Mumbai R&D facility. The openings are available across specialized drug safety functions including Safety Variations, Safety Data Exchange Agreements (SDEA), and Website Review & Compliance Reporting.
These roles offer opportunities to work with global pharmacovigilance systems, regulatory authorities, safety compliance processes, risk management activities, and international drug safety requirements.
Professionals with experience in EU, UK, USFDA, India, and Rest of World pharmacovigilance regulations may find these positions particularly suitable for long-term career growth.
Vacancy Details
| Particular | Details |
|---|---|
| Company | Macleods Pharmaceutical Ltd |
| Department | Pharmacovigilance |
| Location | Andheri, Mumbai |
| Available Positions | Safety Variations, SDEA, Website Review & Compliance Report Activity |
| Qualification | M.Pharm, B.Pharm, BDS, BHMS |
| Experience | 2–5 Years |
| Employment Type | Full-Time |
| Application Mode | |
| Application Email | adityab@macleodspharma.com |
Job Role & Responsibility Explanation
1. Pharmacovigilance – Safety Variations
This role focuses on maintaining drug safety information and ensuring regulatory updates are incorporated into product safety documents.
Key activities include:
- Monitoring global regulatory updates.
- Reviewing EMA, MHRA, HMA, and EC decisions.
- Updating SmPC and PIL documents.
- Supporting safety-related regulatory submissions.
- Coordinating with Regulatory Affairs teams.
- Managing Reference Safety Information (RSI).
- Reviewing innovator product information.
Professionals in this role contribute directly to maintaining compliance with international pharmacovigilance requirements.
2. Pharmacovigilance – SDEA
The Safety Data Exchange Agreement role is responsible for managing agreements between pharmaceutical companies and business partners regarding safety reporting responsibilities.
Major responsibilities include:
- Drafting and reviewing SDEAs.
- Negotiating safety agreements.
- Tracking and maintaining agreement compliance.
- Coordinating with global stakeholders.
- Supporting pharmacovigilance audits.
- Managing reconciliation activities.
- Providing pharmacovigilance training.
- Supporting due diligence activities.
This position requires strong regulatory knowledge and stakeholder management skills.
3. Website Review & Compliance Report Activity
This role focuses on monitoring regulatory websites and preparing compliance-related reports.
Key responsibilities include:
- Reviewing international regulatory authority websites.
- Tracking safety updates.
- Monitoring signal management activities.
- Supporting PSUR-related functions.
- Drafting compliance reports.
- Coordinating with QPPV and local representatives.
- Managing documentation and record archiving.
- Tracking compliance actions and follow-ups.
The role offers exposure to global pharmacovigilance compliance activities.
Eligibility Criteria
Educational Qualification
Candidates should possess any of the following qualifications:
- M.Pharm
- B.Pharm
- BDS
- BHMS
Experience Requirements
Safety Variations
- 3–5 years of Pharmacovigilance experience
SDEA
- 3–5 years of Pharmacovigilance experience
Website Review & Compliance Report Activity
- 2–3 years of Pharmacovigilance experience
Preferred Candidate Profile
- Experience in global pharmacovigilance activities
- Knowledge of international regulatory guidelines
- Strong documentation skills
- Experience in safety compliance management
- Regulatory affairs exposure will be advantageous
Skills Required
Successful candidates should possess:
- Pharmacovigilance operations knowledge
- Drug safety reporting expertise
- Regulatory compliance understanding
- EU and UK regulatory knowledge
- Signal management understanding
- Safety data management skills
- SDEA management experience
- Technical writing skills
- Medical document review abilities
- Analytical thinking
- Attention to detail
- Communication skills
- Team collaboration capabilities
- Audit and inspection readiness knowledge
- Time management and organizational skills
Estimated Salary
The company has not officially disclosed compensation details.
Based on current industry trends and experience requirements, professionals in these positions may expect an estimated annual salary range of:
₹6 LPA – ₹15 LPA
Actual salary may vary depending on:
- Experience level
- Technical expertise
- Previous pharmacovigilance exposure
- Interview performance
- Internal compensation policies
Interview Details
At the time of publishing, Macleods Pharmaceutical has not announced a walk-in interview.
Selection Process
The likely hiring process may include:
- Resume Screening
- HR Discussion
- Technical Interview
- Managerial Interview
- Final Selection
Only shortlisted candidates may be contacted by the recruitment team.
Required Documents
Applicants should keep the following documents ready:
- Updated Resume/CV
- Educational Certificates
- Degree Certificates
- Government ID Proof
- Passport Size Photograph
- Experience Certificates
- Current Salary Documents (if applicable)
- Latest Increment Letter
- Previous Employment Documents
- Pharmacovigilance Training Certificates (if available)
How to Apply
Interested and eligible candidates can apply by sending their updated resume to:
Email: adityab@macleodspharma.com
Suggested Email Subject
Application for Pharmacovigilance Position – [Safety Variations / SDEA / Website Review]
Candidates should clearly mention their relevant experience and preferred position in the email.
Frequently Asked Questions (FAQs)
Q1. Is this opportunity open for freshers?
No. These positions require relevant pharmacovigilance experience ranging from 2 to 5 years.
Q2. What qualifications are accepted?
M.Pharm, B.Pharm, BDS, and BHMS candidates are eligible depending on the role requirements.
Q3. Where is the job location?
The positions are based at Macleods Pharmaceutical's R&D facility in Andheri, Mumbai.
Q4. Is SDEA experience mandatory?
For the SDEA role, previous exposure to Safety Data Exchange Agreements is highly beneficial and may be preferred.
Q5. What regulatory guidelines should candidates know?
Candidates should be familiar with EU, UK, USFDA, India, and other global pharmacovigilance regulations.
Q6. How can I apply?
Candidates can send their updated resume to adityab@macleodspharma.com.
Q7. Is there any application fee?
No official application fee has been mentioned.
Q8. What is the career scope after joining?
Professionals can progress toward Senior Drug Safety Associate, PV Specialist, PV Manager, Regulatory Affairs Manager, Safety Scientist, or Global Pharmacovigilance Lead roles.
Final Conclusion
The latest Pharmacovigilance recruitment announced by Macleods Pharmaceutical Ltd presents an excellent opportunity for experienced professionals seeking career growth in drug safety, regulatory compliance, SDEA management, and pharmacovigilance operations. With specialized openings across multiple pharmacovigilance functions, candidates can gain exposure to global safety systems, regulatory authorities, compliance reporting, and international drug safety standards.
Professionals possessing strong pharmacovigilance expertise, regulatory knowledge, and safety documentation experience are encouraged to apply and explore this opportunity with one of India's leading pharmaceutical companies.
Disclaimer
The information provided above is based on the recruitment announcement released by the employer. Candidates are advised to verify all details, eligibility requirements, responsibilities, and application procedures directly with the company before applying.
Note: Pharma Duniya does not charge any money for job information. Candidates are advised to verify details from the official company website.
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