Pharmacovigilance (PV), QMS and Regulatory Compliance Manager/Senior Manager
Wellthy Therapeutics Pvt Ltd
Mumbai, MH, in
3d ago

Job Information

Industry Health Care Work Experience 5+ years Salary 10 - 14L City Mumbai State / Province Maharashtra Zip / Postal Code 400008

Experienced in :

You have about 5 to 8 years of a strong background in Global Healthcare and LifeSciences environment with skills and experience of overall management of regulatory compliance, managing QMS and pharmacovigilance operations activities encompassing :

Compliance with Indian laws, EMA, US FDA, PDPA etc reporting and requirements

Recruit, manage and train pharmacovigilance operation teams

Develop and maintain policies and procedures for collection, processing and regulatory reporting of adverse events

Coordinate review and verification of incident reports for completeness and consistency

Support the needs of key internal stakeholders : Accounts, Business and Care Delivery

Support the needs of the key external stakeholders : Key Accounts, Key Opinion Leaders and Partners

Operate within expense budgets and recommend pharmacovigilance investments based on ROI

Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented

Determine if appropriate sources of product and quality problems have been identified Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action

Determine if sources of product and quality information that may show unfavorable trends have been identified Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action

Challenge the quality data information system and verify that the data received by the CAPA system are complete, accurate and timely

Strong knowledge of product development process and regulations relating to post-marketing safety

Adept with technology systems; experience with a pharmacovigilance databases

Excellent oral and written communication skills including presentation skills

Demonstrated technical writing skills

Excellent communication and time management skills to manage multiple projects at any one time

You are a strong team member and understand the need for effective communication at all levels

You will have a demonstrable record for effective relationship building with clients and colleagues and you are confident in presenting to same with high standards for the quality of material presented

Main Duties :

Ensures effective functioning of all PV requirements in projects in compliance with client agreement, contract; and local and global regulatory guidelines

Responsible for quality management, compliance management and document management across all projects

Responsible for recruitment of new staff in the PV Department

Is involved in objective setting and annual appraisals of staff

Continuously works with internal and external clients to ensure satisfaction

Ensures pharmacovigilance aspects of projects are managed in line with budgets and agreed timelines to achieve client satisfaction

Train and mentor PV department staff, as needed

Represents PV / QMS / Compliance department during client audits or regulatory authority inspections

Generates and reviews departmental SOPs and Working Procedures

Manage, lead Digital Health accreditation requirements including planning, preparation, integration and implementation

Provide expertise in training, supervision and support to staff in the development of knowledge and skills in quality improvement activities

Coordinate and provide advice on the review of critical and adverse incidents and / or Root Cause Analysis and ensure progress on the implementation of recommendations arising from such reviews

Take a leadership role in risk management assisting with the development, enhancement and implementation of appropriate risk management policies, procedures and systems

Develop and implement an organisation wide Quality Plan that describes activities and outcome measures that ensure compliance with all Standards relevant to Digital Health

Collect and analyse data and trends on aspects of quality, risk and safety and report findings that stimulate continuous improvement

Negotiate and manage internal and external reviews and audits and lead the implementation of audit recommendations and actions, ensuring evaluation processes are effectively applied

Use data to present quality and safety information to staff

Assist with the development of the Annual Quality Account

Manage ISRM resources and requirements and has working knowledge of information security technologies

Be the Data Protection Officer (DPO) in the organisation and ensure our company is compliant with the General Data Protection Regulation (GDPR), PDPA, HIPAA and 21CFR Part 11, ISO 27001, ISO 27701 etc requirements and all such national and international requirements for the markets we operate in or get into, including creation of policies that enforce compliance with legislation and deliver trainings to all employees to increase awareness of data protection measures

Education

Graduate, postgraduate, in a scientific or healthcare discipline

Certification / Specialization in Clinical Research (not mandatory)

Energetic

Strong attention to detail

Strong interpersonal skills

Proactive

Excellent planning and problem solving skills

Confidence and influencing

Logical thinking, accurate and analytical

Ability to work independently and as part of a team

Self-starter

Ability to coach / mentor others

Commercially astute

Customer focused and service orientated

Ability to work through Change

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