Macleods Pharmaceutical Ltd has announced new openings in its Pharmacovigilance Department at R&D, Mumbai. The current Macleods Pharma hiring drive covers three specialized Pharmacovigilance profiles: SDEA, Aggregate Report Medical Reviewer, and Safety Variations.

These Pharmacovigilance jobs in Mumbai are suitable for experienced B.Pharm, M.Pharm, M.Sc, MBBS and BAMS candidates, depending on the role. The openings involve important drug-safety functions such as Safety Data Exchange Agreement management, aggregate report medical review, regulatory safety variations, SmPC/PIL updates, and Pharmacovigilance compliance.

Freshers are specifically advised not to apply, as relevant experience is required for all three profiles.

Macleods Pharma Pharmacovigilance Vacancy Overview

Role 1: SDEA – Pharmacovigilance

Number of Positions: 1
Qualification: B.Pharm / M.Pharm / M.Sc
Experience Required: 2–5 years
Profile: Safety Data Exchange Agreement (SDEA)

The SDEA position is focused on the global management of Safety Data Exchange Agreements in accordance with applicable Pharmacovigilance regulations and internal procedures.

Roles & Responsibilities – SDEA

• Manage global Safety Data Exchange Agreements in accordance with applicable regulatory requirements.
• Draft, review, revise, negotiate, track, archive and implement SDEAs.
• Create new SDEAs based on commercial agreement terms and the company’s standard SDEA templates.
• Ensure appropriate Pharmacovigilance provisions are incorporated into new agreements.
• Liaise with global, regional and local stakeholders across Safety, Quality, Regulatory Affairs, Clinical Research, Business Development, Supply, Marketing, Commercial, Legal and affiliate teams.
• Coordinate SDEA preparation, review, approval, execution, tracking and archival.
• Perform monthly reconciliation with SDEA partners.
• Maintain processes to ensure implementation and compliance after an SDEA is signed.
• Provide SDEA information required to support relevant sections and annexes of the PSMF.
• Support PV due diligence for product acquisitions and divestments where required.
• Act as an SDEA subject matter expert during audits and regulatory inspections.
• Serve as a key contact for internal stakeholders and external business partners on SDEA matters.
• Provide Pharmacovigilance training related to ADR reporting to the MAH.
• Complete SDEA partner audit questionnaires as required.
• Conduct SDEA-related training programs.

Desired SDEA Skills

Candidates should have knowledge of global Pharmacovigilance regulations covering the European Union, United Kingdom, United States, India and other emerging/ROW markets.

Applicants should also possess:

• Previous SDEA management experience.
• Understanding of Pharmacovigilance operations.
• Knowledge of commercial agreements and their relationship with PV responsibilities.
• Strong written and verbal communication.
• Negotiation and stakeholder-management skills.
• Good teamwork and interpersonal abilities.
• Strong organizational and time-management skills.

Role 2: Aggregate Report Medical Reviewer

Number of Positions: 2
Qualification: MBBS / BAMS
Experience: 1–2 years of medical review of PSUR/PBRER/RMP/ACO documents
Profile: Aggregate Report Medical Reviewer

This Aggregate Report Medical Reviewer job at Macleods Pharmaceuticals is intended for medical professionals with relevant Pharmacovigilance and aggregate safety reporting experience.

Roles & Responsibilities

• Perform medical review of PSUR, PBRER, ACO and RMP aggregate safety reports.
• Manage queries received from regulatory agencies and authorities.
• Resolve medical and scientific queries raised by the aggregate reporting team.
• Assist with updating SOPs and supporting guidance documents related to aggregate reports.
• Assist in deviation and CAPA documentation.
• Participate in and support Pharmacovigilance audits and regulatory inspections.
• Ensure aggregate reports are medically accurate and aligned with applicable regulatory requirements.

Technical Skills & Requirements

Candidates should possess:

• Knowledge of Microsoft Office, including Word and PowerPoint.
• Strong written and verbal communication skills.
• Knowledge of applicable regulatory guidelines, including EMA and MHRA requirements and requirements relevant to markets such as South Africa, Kazakhstan and Ukraine.
• Relevant clinical understanding.
• Approximately 6–12 months of clinical and/or ICSR medical review experience, as specified in the vacancy.
• Experience with aggregate report medical review.

Eligible Education: MBBS / BAMS

Role 3: Safety Variations – Pharmacovigilance

Number of Positions: 1
Qualification: B.Pharm / M.Pharm / M.Sc
Experience Required: 3–5 years
Profile: Safety Variations – Pharmacovigilance

The Safety Variations role involves monitoring regulatory safety information and implementing appropriate changes to product information, particularly for the European and UK markets.

Roles & Responsibilities – Safety Variations

• Update SmPC and PIL documents for Europe and the UK based on applicable requirements and regulatory outcomes.
• Monitor safety-related updates from PRAC, CMDh, CHMP and other relevant regulatory mechanisms.
• Search regulatory websites for new safety information and regulatory updates.
• Monitor sources including EMA, MHRA, European Commission decisions and HMA resources.
• Coordinate with the Regulatory Affairs department regarding innovator information, common text and regulatory queries.
• Review and monitor regulatory updates for safety-related labeling changes.
• Search for country-specific innovator/reference product information where required.
• Periodically compare and review European and UK SmPC/PIL documents in accordance with SOPs.
• Identify safety changes requiring regulatory filing.
• Update relevant Reference Safety Information (RSI).
• Communicate required safety variations to the Regulatory Affairs team.

Skills Required for Safety Variations

Candidates should have a good understanding of:

• Pharmacovigilance regulations
• SmPC and PIL
• Reference Safety Information
• EMA and MHRA requirements
• PRAC recommendations
• CMDh and CHMP procedures
• Safety-related labeling changes
• Regulatory intelligence
• Pharmacovigilance and Regulatory Affairs coordination

Who Can Apply?

The qualification depends on the position.

For SDEA: B.Pharm, M.Pharm or M.Sc candidates with 2–5 years of relevant experience.

For Aggregate Report Medical Reviewer: MBBS or BAMS candidates with 1–2 years of relevant aggregate medical review experience and the specified clinical/ICSR medical review exposure.

For Safety Variations: B.Pharm, M.Pharm or M.Sc candidates with 3–5 years of relevant Pharmacovigilance/safety variation experience.

Important: These are experienced-hire positions. Freshers should not apply.

Why Consider These Pharmacovigilance Roles?

These Macleods Pharma Pharmacovigilance jobs provide exposure to specialized areas of drug safety beyond routine ICSR case processing. Depending on the profile, selected professionals may gain experience in:

• Global Safety Data Exchange Agreements
• Pharmacovigilance compliance
• Aggregate safety reporting
• PSUR/PBRER and RMP activities
• Medical review
• Safety labeling and variations
• SmPC/PIL management
• Regulatory intelligence
• Audit and inspection readiness
• Cross-functional PV and Regulatory Affairs activities
• Global regulatory requirements

Such experience can be particularly relevant for professionals looking to develop careers in Pharmacovigilance compliance, aggregate reporting, safety agreements, safety labeling, PV quality and regulatory safety operations.

How to Apply for Macleods Pharma Pharmacovigilance Jobs

Interested and eligible candidates can send their updated resume to:

Email: adityab@macleodspharma.com

Candidates should clearly mention the role/profile they are applying for in the email subject line, such as SDEA, Aggregate Report Medical Reviewer, or Safety Variations.