Pharmacovigilance - SERM

Role Brief:

Incumbent will be a part of the SERM team, working on SERM related activities.

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 Glenmark products including (but not limited to) the preparation of safety reports, risk management plans and signal assessments.

Role & responsibilities:

1) Author/ review/ approve drug safety reports

2) Contribute to the development and implementation of Risk Management Plans

3) Perform signal detection, evaluation and overall signal management activities

4) Lead or participate in cross-functional safety review teams for products in clinical development

5) Review and provide input into safety sections of study related documents

6) Respond to regulatory authority/healthcare professionals queries for assigned products

7) Review literature search results for ICSRs and articles for inclusion in safety reports

8) Liaise and collaborate with other GPV functions, international Glenmark affiliates and external business partners

9) Support product labelling activities

10) Support audits, inspection and CAPA management relating to SERM activities

11) Support assessment and implementation of regulatory intelligence findings that impact SERM activities

12) Provide technical guidance in the development and maintenance of procedural documentation

13) Support organizational initiatives in driving global operational excellence in Pharmacovigilance

14) Support the EEA QPPV

15) Clinical Trial support

16) Vendor Management

17) Website Monitoring

Preferred candidate profile :

4 + years of experience within PV & SERM

M.Pharm preferred