About Glenmark Pharmaceuticals Mumbai:
Glenmark is a leading global innovative pharmaceutical company committed to enriching lives worldwide. Our vision is to discover possibilities and make the lives of patients better across the globe by developing cures for unmet medical needs. We have a rich pipeline of innovative molecules in various phases of development which are targeted in areas of oncology, respiratory and dermatology. Our Generics business spans multiple geographies with the US being our largest market followed by India. Our effort is to make high-quality affordable medication accessible to patients across the world. Through our generics medicines, we impact over 100 million patients each year globally. We are also a global supplier of high-quality API products and a preferred partner for pharmaceutical companies worldwide. Our 14,000 employees globally are dedicated to our goal of enriching lives globally.
Our values – Achievement, Respect and Knowledge bind our workforce together and consistently fuel our growth. At Glenmark, we have created a culture which allows our talent to deliver their best and create positive outcomes for themselves, the organization and the community at large. Through Glenmark Foundation, our CSR activities are largely focused in the areas of Child Health and over the years we have impacted over 900,000 lives globally.
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About Glenmark Pharmaceuticals Mumbai Jobs Details:
Glenmark Pharmaceuticals is hiring …
- Experience: 3 – 6 years.
- Job Location: Mumbai
Job Highlights
- Physician, pharmacist,) or life science Postgraduate with an, MSc or PhD degree
- Good understanding of drug development process and drug safety regulatory requirements (EU, US regulations as well as ICH and GCP Guidelines)
- 3 to 6 years of drug safety experience in a biotechnology or pharmaceutical company or CRO environment.
Job description
Position Summary
The Safety Evaluation and Risk Management (SERM) group within GPV is responsible for the scientific evaluation of safety information and the continuous monitoring of the benefit-risk profile of all Glenmark products throughout all stages of the product lifecycle. The SERM works to ensure that Glenmark is compliant with global legislation and guidelines that govern the development, registration and commercialization of its medicines.
The SERM scientist is responsible for all safety evaluation and risk management activities for a portfolio of Glenmark products, including (but not limited to) the preparation of safety reports, risk management plans and signal assessments.
Roles and Responsibilities
- Author drug safety reports
- Contribute to the development and implementation of Risk Management Plans
- Perform signal detection and evaluation
- Respond to regulatory authority/healthcare professionals’ queries for assigned products
- Review literature search results for ICSRs and articles for inclusion in safety reports
- Liaise and collaborate with other GPV functions, international Glenmark affiliates and external business partners
- Support product labelling activities
- Support audits, inspection and CAPA management relating to SERM activities
- Support assessment and implementation of regulatory intelligence findings that impact SERM activities
- Support organizational initiatives in driving global operational excellence in Pharmacovigilance
- Support the EEA QPPV
Desired Candidate Profile
- Healthcare professional (e.g. physician, pharmacist,) or life science Postgraduate with an MSc or PhD degree.
- 3 to 6 years of drug safety experience in a biotechnology or pharmaceutical company or CRO environment
- Good understanding of drug development process and drug safety regulatory requirements (EU, US regulations as well as ICH and GCP Guidelines)
- Excellent written and verbal communication including presentation skills
- Fluent in medical terminology
- Ability to prioritize and multi-task successfully in a fast-paced environment
- Ability to interpret and follow regulatory guidelines
- Ability to react constructively in a high-energy and fast-paced environment
- Ability to work autonomously, as well as act as a strong team player
- Excellent interpersonal, analytical, negotiation, decision-making and problem-solving skills
- Ability to establish and maintain transparency within the organization and with authorities.
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FAQ Related To Glenmark Pharmaceuticals:
Q. Which is the official website of Glenmark Pharmaceuticals?
Ans: https://glenmarkpharma.com/
Q. Where is Glenmark Pharmaceuticals headquarters located?
Ans: Glenmark Pharmaceuticals’ headquarters is in Mumbai, Maharashtra, India.
Q. Who is the owner of Glenmark?
Ans: Glenn Mario Saldanha
