PharmaLex is Hiring for experienced Safety Writing professionals

Location: Noida/Mumbai/Bangalore
Position: Assistant Manager / Manager
Relevant Experience: 8-12 Years

Please find the job description of Safety Writing position.

– Development, authorship and tracking of Safety Reports (PSUR/RMP/ACOs) to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely manner. Initiates the tracking of commitments and liaises with relevant functions that maintain and monitor the commitments.
-Responsible for the implementation of operational tasks in the field of Safety writing.
-Overseeing the service performance.
-Mentoring employees enabling them to work independently within timelines, budget, and quality.
-To organize the kick off meeting, prepare PSURs & RMP’s as per the client’s SOPs and working practices, review of the document for medical cohesiveness, characterization of safety concerns, to ensure quality of the draft during preparation of RMP/PSUR/ACOs.
-In collaboration with required teams, development and authorship of high quality and regulatory compliant PSUR-PBRER, RMP, ACO & DSURs.
-Coordinates activities from the different line units to ensure all documents required to support the RMP/PSUR/ACO main document are included in the annexes.
-Manage all logistical aspects related to the timely development of the safety reports, work with authors of the different line functions to ensure the content meets client and Health Authorities requirements.
-Updates the RMP according to HA requirements and make sure they are aligned with other regulatory documents such as the Periodic Safety Update Report (PSUR), CDS, etc.
-Ensure consistency and regulatory compliance of RMP/PSUR/ACO sections and annexes.
-Tracks Health Authorities feedback and assessment on RMP/PSUR/ACO and ensures HA requirements are implemented as required (e.g. in individual RMP, in global RMP template).
-Provides expertise required for the finalization of the RMP/PSUR/ACO and its annexes. Resolve issues as they arise. Ensures proper maintenance of all RMP/PSUR/ACO documents as per process.
-Develops and dispatches product-specific training slides for both internal and training of 3rd party, and ensure RMP/PSUR/ACO approved by HA or RMP/PSUR/ACO updates are dispatched as per requirement.
-Peer-review (data and scientific review) & populate QC checklist.
-To address the comments by the various stake-holders.
-Preparation of response to questionnaire to address HA request, – –Evaluation of the safety database/literature/CT data/epidemiology data to address HA response/request.
-Formulating strategy for safety issues/response to health authority requests and integrated benefit-risk evaluation.
-To address the comments by the various stake-holders. 

Interested candidates can send their resumes at swati.chhabra@pharmalex.com.