Medical Writer PSMF Jobs in Mumbai at Alkem Laboratories
Introduction
Professionals with experience in pharmacovigilance documentation and regulatory medical writing now have an excellent opportunity to advance their careers with a leading pharmaceutical organization. Alkem Laboratories is inviting applications for the position of Medical Writer – PSMF at its Mumbai location. This role is ideal for candidates who have hands-on exposure to Pharmacovigilance System Master Files (PSMFs), PV system documentation, and compliance with global regulatory requirements. Medical Writer PSMF Jobs in Mumbai
The position offers a stable work environment, exposure to international regulatory frameworks, and the chance to work closely with cross-functional pharmacovigilance and regulatory teams.
Company Overview
Alkem Laboratories is one of India’s most established multinational pharmaceutical companies with a strong presence in domestic and international markets. The company operates across more than 50 countries and is known for its robust portfolio in branded generics, acute and chronic therapies, and regulatory-compliant manufacturing.
With a consistent focus on quality, compliance, and patient safety, Alkem continues to invest heavily in pharmacovigilance systems and medical writing functions to meet evolving global regulatory expectations.
Job Location & Employment Type
- Location: Mumbai, Maharashtra
- Employment Type: Full-time
- Work Mode: On-site
- Department: Pharmacovigilance / Medical Writing
Open Positions / Department Details
- Job Title: Medical Writer – PSMF
- Functional Area: Pharmacovigilance Documentation
- Role Category: Medical Writing – Regulatory Safety
- Experience Level: Mid-level professional
This role supports the pharmacovigilance function with a primary focus on PSMF development, maintenance, and regulatory readiness. Medical Writer PSMF Jobs in Mumbai
Key Roles & Responsibilities
The Medical Writer – PSMF will be responsible for managing and maintaining pharmacovigilance system documentation in compliance with global regulatory requirements. Major responsibilities include: Medical Writer PSMF Jobs in Mumbai
- Preparing, updating, and maintaining Pharmacovigilance System Master Files (PSMFs) for assigned regions
- Tracking submission schedules and ensuring adherence to regulatory timelines and commitments
- Ensuring PSMF content remains accurate, complete, and aligned with current SOPs, work instructions, and regulatory updates
- Managing document control activities including version management, archival, and traceability
- Developing and maintaining Pharmacovigilance System Summaries and related safety documentation
- Coordinating with internal teams such as Pharmacovigilance, Regulatory Affairs, Quality, and Business functions to collect and validate required inputs
- Collaborating with affiliates, partners, and external stakeholders to finalize regional PSMFs
- Supporting the development, review, and revision of SOPs and procedural documents related to PSMF activities
- Assisting during internal audits, regulatory inspections, and health authority queries involving PSMF and PV system documentation
- Ensuring inspection readiness by maintaining consistent and audit-ready documentation
- Contributing to continuous improvement of documentation processes and compliance practices
Medical Writer PSMF Jobs in Mumbai
Eligibility Criteria
Education
- Degree in Pharmacy, Life Sciences, Medicine, or a related scientific discipline
Experience
- Minimum 2 years of relevant experience in:
- Medical Writing – PSMF
- Pharmacovigilance documentation
- PV system compliance
Skills Required
Candidates should demonstrate strong technical and professional competencies, including: Medical Writer PSMF Jobs in Mumbai
- In-depth understanding of Pharmacovigilance System Master Files (PSMFs)
- Knowledge of global pharmacovigilance regulations, with preference for EU GVP Module II exposure
- Experience in SOP development, document management systems, and regulatory compliance activities
- Strong written communication skills with the ability to produce clear, structured, and compliant documents
- Ability to manage multiple regulatory timelines and priorities effectively
- High attention to detail and strong quality mindset
- Proven ability to collaborate with cross-functional and cross-regional teams
- Confidence in supporting audits, inspections, and health authority interactions
Salary & Benefits
- Estimated Salary Range: ₹8,00,000 – ₹14,00,000 per annum
- Salary will be offered as per company norms, based on experience, skill set, and interview performance
- Additional benefits include a professional work environment, structured processes, and long-term career stability
Medical Writer PSMF Jobs in Mumbai
Selection Process
The hiring process may include:
- Application shortlisting
- Technical or functional interview
- Managerial discussion
- Final HR interaction
Selection stages may vary depending on business requirements.
How to Apply
- Application Mode: Online Application
- Interested candidates should apply through the official company career portal or the authorized job application link provided by the employer.
Important Dates
- Applications are accepted until the position is filled. Early application is recommended.
Why Apply for This Pharma Job?
This role offers a valuable opportunity to work within a mature pharmacovigilance system at a reputed multinational pharmaceutical company. Candidates gain exposure to global PV regulations, inspection readiness activities, and structured medical writing processes. With strong internal systems and long-term growth prospects, this position is well-suited for professionals aiming to build a specialized career in regulatory medical writing and drug safety. Medical Writer PSMF Jobs in Mumbai
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not associated with Alkem Laboratories or any other organization. Job details are shared strictly for informational purposes. Candidates are advised to verify information and apply only through official and authorized sources. Medical Writer PSMF Jobs in Mumbai
Final Call-to-Action
If you have experience in PSMF preparation and are looking to strengthen your career in pharmacovigilance medical writing, this opportunity in Mumbai is worth exploring. Submit your application at the earliest and take the next step in your professional growth. Medical Writer PSMF Jobs in Mumbai
