Medical Writer - PSMF

About Alkem:

Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the top five pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India.

Roles and Responsibilities:

1. Prepare and maintain schedules and trackers to ensure timely preparation and submission of PSMF
2. Develop and maintain regional PSMFs reflecting the current pharmacovigilance system regulatory requirements.
3. Ensure all PSMF sections are accurate, complete and updated following any system changes per SOPs, WIs, and regulations.
4. Manage PSMF document control (version control, archiving).
5. Develop and maintain PV System Summaries.
6. Collaborate with internal stakeholders to gather information and align on terms.
7. Communicate with partners to finalize PSMF.
8. Liaise with cross-functional teams, including regulatory, and business functions, to gather input for PSMF.
9. Prepare and contribute to the preparation of Standard Operating Procedures (SOPs) for PSMF.

10.Support audits and inspections related to PSMF activities.