Manager – DSRM (aggregate and SDEA) (Airoli, MH, IN) bei Lupin Limited

Manager - DSRM (Aggregate and SDEA)

1. Managing the Safety Data Exchange Agreement mailbox, to track the emails received and ensure appropriate action is taken.
2. To ensure appropriate agreements are in place with prospective and existing business partners and ensure timely execution and renewal of agreements
3. To liaise with cross functional teams to seek additional information
4. To ensure compliance to the agreements and be audit / inspection ready.

5.Preparing and maintaining the aggregate report writing plan to plan and keep a track of the global aggregate report submissions

6. Preparing and maintaining the aggregate report compliance tracker and ensuring compliance and appropriate corrective and preventive actions

7. Maintenance and regular update of global / regional risk management measures tracker
8. Ensuring the implementation of additional risk minimization measures (aRMMs) and timely evaluation of the effectiveness check of additional risk minimization measures for Lupin products globally
9. To liaise with cross functional teams like regulatory affairs, marketing, local affiliates in ensuring appropriate implementation of the risk management plan.

Competencies

B. Phram / M. Pharm

7-8 years of experience in Aggregate Reports, Buiseness partner agreements

7-8 years of experience in Aggregate Reports, Risk Management Plans and Business partner agreements.