Senior Manager - Drug Safety & Risk Management Plan - Pharmacovigilance - US/EU Market

Senior Manager DSP ( RMP )

We are seeking a seasoned professional with 5-7 Years (Minimum 2-3 years of experience in Drafting & review of RMP (Risk Management Plan)). Experience in Innovator Product/client is required.

Should have handled US/EU Market.

Job Description:

- Perform daily work for generation (preparation and/or review) of Risk management plan or Risk Evaluation and Mitigation Strategy (REMS), additional risk minimization measures (aRMM) effectiveness assessment reports; Periodic review reports, RMM tracking with REMS support and any other tasks relevant to Pharmacovigilance department as per the Regulations and Standards Operating Procedures (SOPs).

- Prepare and maintain schedules of periodic review and effectiveness assessment of aRMMs.

- Evaluate information coming in from various internal and external sources like signal team or regulatory intelligence team or PRAC procedural outcomes and identify if an RMP update is needed.

- Execution of Company SOPs and management of compliance with the company SOPs and regulatory requirements.

- Tracking of aRMM implementation.

- Support to signal detection team as and when needed.

- Train and mentor new employees in pharmacovigilance.

- Generation and review of SOPs and Wis.

- Liaise effectively and maintain excellent relationship with the internal/ external contacts.

- Maintain awareness of changes to/ new regulations affecting pharmacovigilance activities.

- Communicate new or changed regulations to management and to relevant members of the department to initiate any change in processes.

- Builds and maintain good relationships across functional units and company affiliates.

- To contact, as required UK/ US office(s) and clients to achieve required outcomes and meet timelines.

- Compliance to project guidelines.

- To carry out necessary administrative duties required for the job.

- Other duties as assigned by management.