Executive, Pharmacovigilance & Drug Safety at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

24 May, 26

Salary

0.0

Posted On

23 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Drug Safety, Signal Detection, Signal Analysis, Signal Evaluation, Adverse Drug Reaction, ADR Sheet Preparation, Drug Safety Report, DSR Authoring, Regulatory Compliance, SOP Maintenance, Training, Risk Management, Label Changes, Benefit-Risk Profile Assessment, Signal Management

Industry

Pharmaceutical Manufacturing

Description

Job Description: ❖ Prepare and maintain the Signal Schedule as per Standard Operating Procedures. ❖ Identification, Analysis, and Evaluation of safety signals arising from various data sources to determine signals or risks that could result in changes to labels and / or benefit-risk profile of the product. ❖ Evaluate the safety information and prepare product specific ADR (Adverse Drug Reaction) Sheet. ❖ Author Drug Safety Report (DSR) for Valid signals as per Standard Operating Procedures. ❖ Communicate findings from routine and ad hoc signal detection and assessment activities to concerned stakeholders. ❖ Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal detection. ❖ Maintain awareness on new or revised regulatory requirements and guidelines relevant to Signal Management. ❖ Ensure regulatory compliance (quality, procedures, regulations, timeliness, consistency) for Signal Management process. ❖ Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents concerning Signal Management. ❖ Impart trainings related to Signal Management activities, as and when required Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key roles that the Human Resources team performs: Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions. Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures. Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance. Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

Responsibilities

The role involves preparing and maintaining the Signal Schedule, identifying, analyzing, and evaluating safety signals from various data sources to assess product risks and potential label changes. Responsibilities also include authoring Drug Safety Reports (DSR) and communicating findings to stakeholders.