Manager, Pharmacovigilance, Epidemiology & Risk Management

World Courier

4 - 9 years

7 - 11 Lacs

Noida

Posted:5 days ago| Platform:

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Skills Required

Training Root cause analysis Publishing Project management Resource allocation Legal Archiving Pharmacovigilance Risk management Operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection.
Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER) and Clinical Expert Statements.
Publishing, distribution, archiving and submission of safety reports.
Preparation of Signal detection reports, including EVDAS screening if applicable.
Preparation of SARs (Signal Assessment Reports).
Writing Risk Management Plans (RMPs). Identifying safety concerns and providing advice with regard to future risk minimisation activities for the entire life cycle of the product. Reviewing the documents, checking for completeness and consistency, and evaluating the report quality.
Preparation of responses to PRAC assessment reports and other Authority requests (eg, referrals, etc).
Performing signal detection and signal analysis of safety data, provide the appropriate expert advice as we'll as assisting in communication with regulatory agencies when the new data has an effect on the risk-benefit balance.
SOP services/writing and review of SOPs, WIs and related documents and training material in the area of pharmacovigilance for clients (including implementation and training.
Development of customer-specific solutions and processes in cooperation with clients.
Build, develop and maintain working relationships with clients.
Ensure client satisfaction and compliance with legal and regulatory requirements.
Representation of the company and the team with clients, authorities and professional institutions. Inform the Head of the Pharmacovigilance Team/Service Line Lead regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to present solutions. Management of parts of a project or the complete project.
Fulfilling highly complex, sophisticated tasks within the area of pharmacovigilance.
Trigger a non-conformity when any performance deviation from the target KPI (Key Performance Indicator) is detected, issue evaluation and root cause analysis, assign corrective actions with a due date to the most appropriate employee, ensure that all agreed actions are completed by the due date.
Communicate proactively with clients about the status of the project and provide solutions to address process deviations, quality issues and inefficiencies.
Development of processes and/or tools within the area of pharmacovigilance in collaboration with the Head of the team and the Head of the Pharmacovigilance Department.
Design and prepare Standard Operational Procedures, Working instructions and Client Specifications for Pharmacovigilance processes, ongoing revisions and implementation of updates. Contribute to achievement of departmental goals, Identify and discuss out-of scope activities that affect project invoicing.
Client audits (preparation of the audit, defend it, review the audit report and follow action plan). Contribute to resource needs and resource allocation to ensure compliance, identification and implementation of process efficiency needs and solutions, Leadership and coaching of employees; Conduct of probation period, annual employee feedback and goal setting meetings, Identification of training needs for employees to help them perform and grow in future role.
The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.

Experience: Minimum 4 Years in writing Risk Management Plans, Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER) and Clinical Expert Statements.

Qualification: B.Pharm/M.Pharm
Open to work from Noida location

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