: Provide administrative support for the preparation of safety writing deliverables (aggregate safety reports, risk management plans, regulatory authority assessment report responses and custom safety reports) for both developmental and market-authorised products. Supports routine project implementation and coordination activities for assigned safety writing deliverables including mailbox triage, aggregate report schedule maintenance, drafting report planning communications and final document formatting. Effectively communicates with managers, project team members, and client contacts. Reviews regulatory/pharmacovigilance publications and information sources to keep the team up to date on current regulations, practices and procedures. Participates in PV process improvement initiatives. Provides mentoring and work direction to more junior level staff. May additionally provide support for scientific services on an ad-hoc basis
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