Piramal Healthcare Limited A major force in the pharmaceuticals and healthcare segment, Piramal Healthcare Limited, incorporating Healthcare Solutions & Pharma Solutions, has an unequivocal vision – to become the most admired pharmaceutical company, with leadership in market share and profits.
Post: Senior Executive / Executive - Clinical Phamacovigilance
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Job Description:
* Primary point of contact for investigator and Investigator Designee(s) to report SAEs.
* To prepare draft CIOMS forms and draft SAE Narratives for SAEs.
* To report SAEs to Regulatory authority and participating Investigators.
* To maintain SAE logs.
* To maintain and update safety files.
* Data entry of adverse events (AEs) for trend analysis.
* To liaise between various departments regarding regulatory and quality compliance of safety reporting.
* Assist the safety monitor in AE-SAE reconciliation.
* Resolving data management queries in consultation with the safety monitor.
* Responding to queries of site personnel and in-house team members.
* Maintain close contact with all functions of CRD especially the clinical operations team and facilitate smooth functioning of the safety team.
* To help safety monitor in post marketing activities for Piramal Critical care products.
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Candidate Profile:
B. Pharm / M. Pharm with PG in Clinical
Relevant drug safety experience ~ 3 years.
Good at Documentation, enthusiastic with relevant clinical qualification. Good team player, good communication, coordination skills.
Additional Information:
Education : B. Pharm / M. Pharm with PG in Clinical
Department: CR-Pharmacovigilance
Experience : min. 3 years
Location : Mumbai
Functional Area: CR
Job code : PLSL/PVS 1
Interested candidates may send us their CVs by 15th December 2011.
Applications may be sent to research.recruitment@piramal.com. The subject line may read 'Application for PVS - I'.
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