Glenmark Pharmaceuticals is hiring for an Executive – Risk Management Plan (Pharmacovigilance) position at its Mahape, Navi Mumbai location. This opportunity is particularly relevant for experienced pharmacovigilance professionals with expertise in Risk Management Plans (RMPs), aggregate safety reports, drug safety regulations, CAPA management, and safety surveillance.
The Executive will join Glenmark Global Pharmacovigilance’s Aggregate Report and Risk Management group. The team is responsible for scientific evaluation of safety information and continuous monitoring of the benefit-risk profile of Glenmark products throughout their lifecycle.
Candidates should have 3+ years of pharmacovigilance experience, particularly in Risk Management Plans and aggregate reporting, along with a good understanding of EU and US drug safety regulations, ICH guidelines, and GCP requirements.
About the Role
The Aggregate Report and Risk Management team within Glenmark Global Pharmacovigilance works to ensure compliance with global legislation and guidelines governing the development, registration, and commercialization of medicines.
As an Executive – Aggregate Reports and Risk Management, the selected candidate will contribute to the preparation and review of aggregate safety reports and Risk Management Plans while maintaining oversight of risk minimization activities.
The position also involves regulatory query management, literature review, audit and inspection support, CAPA and deviation management, procedural documentation, and maintenance of Pharmacovigilance System Master File (PSMF) information.
Key Responsibilities
- Author aggregate safety reports and Risk Management Plans (RMPs) for assigned products.
- Maintain oversight of product risk management and risk minimization activities.
- Review Risk Management Plans and ensure appropriate scientific and regulatory quality.
- Respond to queries received from regulatory authorities and healthcare professionals for assigned products.
- Review literature search results for Individual Case Safety Reports (ICSRs) and identify articles relevant for inclusion in safety reports.
- Collaborate with other Glenmark Global Pharmacovigilance functions, international affiliates, and external business partners.
- Support pharmacovigilance audits and regulatory inspections related to aggregate reporting and Risk Management Plans.
- Ensure audit and inspection requests are addressed within required timelines.
- Participate in CAPA management associated with aggregate reports and risk management activities.
- Provide technical guidance for developing and maintaining pharmacovigilance procedural documentation.
- Support compliance activities performed internally by the Aggregate Report and Risk Management team.
- Ensure CAPAs and deviations are completed within established timelines.
- Maintain relevant PSMF data for the aggregate reporting and risk management function.
Qualification and Eligibility
Candidates interested in the Glenmark Pharmacovigilance Executive job in Navi Mumbai should meet the following requirements:
Education: The job description mentions a Bachelor’s in Pharmacy and Master’s qualification, while the education section specifically lists M.Pharm in any specialization.
Experience: Candidates should have a minimum of 3+ years of total Pharmacovigilance experience, particularly involving Risk Management Plans and aggregate reports.
This is therefore an experienced-hire opportunity and not a fresher Pharmacovigilance position.
Skills Required
Candidates should have practical knowledge or experience in:
- Risk Management Plans (RMP)
- Pharmacovigilance and drug safety
- Aggregate safety reporting
- Risk minimization activities
- Safety surveillance
- ICSR and literature review
- Benefit-risk assessment
- CAPA management
- Deviation management
- PSMF maintenance
- Regulatory authority responses
- EU pharmacovigilance requirements
- US drug safety regulations
- ICH Guidelines
- Good Clinical Practice (GCP)
- Drug development processes
- Pharmacovigilance audits and inspections
- Procedural and compliance documentation
Previous hands-on experience in RMP authoring/review and aggregate safety report preparation will be particularly relevant for this position.
Experience Required
Glenmark has specified 3+ years of Pharmacovigilance experience, especially in Risk Management Plans and aggregate reports.
Professionals currently working in areas such as aggregate reporting, RMP writing, PSUR/PBRER preparation, DSUR reporting, safety surveillance, risk management, or broader pharmacovigilance operations may find this opportunity relevant, provided their experience aligns with Glenmark’s requirements.
Regulatory Knowledge
Applicants should have a good understanding of the drug development process and international drug safety regulatory requirements.
Knowledge of the following frameworks is particularly relevant:
- European Union pharmacovigilance regulations
- United States drug safety requirements
- ICH Guidelines
- Good Clinical Practice guidelines
- Global pharmacovigilance compliance requirements
This regulatory knowledge is important because the position involves preparing safety documentation, responding to health authority queries, supporting inspections, and maintaining compliance across global markets.
Why Consider This Opportunity?
The Glenmark Executive – Risk Management Plan position offers experienced pharmacovigilance professionals exposure to important post-marketing and lifecycle safety activities.
The role provides opportunities to work across aggregate safety reporting, RMP authoring and review, regulatory responses, literature surveillance, CAPA management, audits, inspections, PSMF maintenance, and global pharmacovigilance collaboration.
For professionals building a long-term career in drug safety, aggregate reporting, risk management, safety science, or benefit-risk management, the responsibilities can provide valuable exposure to global pharmacovigilance processes.
Job Location
The position is based at:
Mahape, Navi Mumbai, Maharashtra, India
Candidates should consider their ability to work from the Navi Mumbai location before applying.
How to Apply
