Job Description
The Drug Safety Project Manager manages specific Pharmacovigilence and Drug Safety Services operations associated with assigned products, including the entire adverse events process from trial to post marketing. You will monitor and manage the workflow for assigned projects with responsibility for making decisions regarding adverse event reporting within specific guidelines. Additional responsibilities include but are not limited to:
• Work closely with the clinical operations and project management teams to ensure all PV & DSS activities are performed according to the regulatory and contractual requirements of the study.
• Provide oversight of the receipt and processing of all adverse event reports including entry of safety data, writing patient narratives, and coding adverse events in MedDRA.
• Identify clinically significant information missing from initial reports and collect missing data
• Ensure the cases receive appropriate medical review
• Prepare follow-up correspondence consulting with the medical staff accordingly
Candidate Profile
• University degree in Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry preferred
• A minimum of 7 years experience in Drug Safety*
• Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
• Working knowledge of relevant worldwide pharmacovigilance regulations and guidelines
• Working knowledge of GCP/ICH guidelines related to clinical safety documentation
• Experience with aggregate reporting
• Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance
• University degree in Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry preferred
• A minimum of 7 years experience in Drug Safety*
• Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
• Working knowledge of relevant worldwide pharmacovigilance regulations and guidelines
• Working knowledge of GCP/ICH guidelines related to clinical safety documentation
• Experience with aggregate reporting
• Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance
Additional Information
Experience : 7 years
Qualification : B.Pharm, B.Sc
Location : Mumbai
Industry Type : Pharma
Functional Area : Drug Safety
End Date : 20th December, 2018
Experience : 7 years
Qualification : B.Pharm, B.Sc
Location : Mumbai
Industry Type : Pharma
Functional Area : Drug Safety
End Date : 20th December, 2018
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