• 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 (e.g. referrals etc.).

• Performing signal detection and signal analysis of safety data provide the appropriate expert advice as well 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.

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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: to work from Noida location

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What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.

The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned