Job description

General Manager, Pharmacovigilance (Clinical Trials & Medical Monitoring)

Company: A fast-growing Contract Research Organization (CRO) into Pharmacovigilance, Medical Information, Medical Monitoring, Medical Writing and Regulatory Affairs

Job Title GM - Pharmacovigilance

Department - Pharmacovigilance

Role - To Lead Clinical Trials Client & Medical Monitoring team

Job Location - New Delhi / Ahmedabad

No. of Direct/Indirect reports - 8-10 team members

Position report to - VP : Pharmacovigilance

Experience: 10+ Years of experience and a minimum of 6 years of relevant experience.

1. DUTIES & RESPONSIBILITIES

Pharmacovigilance

- Lead the team managing the offshore client operations for Clinical Trials and Medical Monitoring, covering the day-to-day operations like individual case processing, Periodic Adverse Drug Experience Reports (PADERs) preparation and review, and any other tasks relevant to the Pharmacovigilance Department

- Quality Management of Information and Data Entry and QC & Medical Review (if applicable) of the data entered in company's / client's hosted safety databases.

- Quality Management and review of aggregate reports per the Regulations and SOPs

- Management of Compliance with the Company Standard Operating Procedures and with regulatory requirements

- Generation, Review and execution of Standard Operating Procedures

- Signal detection of the ADRs with cases received from client's products (if required)

- Liaise effectively and maintain excellent relationships with clients and external contacts.

- Resourcing and hiring as per project requirements.

- Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes

- Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders

- Assigning/reassigning tasks to reporting staff

- To carry out the necessary administrative duties required for the job

- To contact, as required, the UK/US office(s) and customers/ clients in order to achieve the required outcomes and meet timelines

- Other duties as assigned by management

- Continuously works with internal and external clients to ensure satisfaction

- Trains and mentors new employees (if required)

- Constantly works towards the identification of new training and development opportunities for the team members

Medical Monitoring :

- Provide medical oversight regarding protocol exemptions, protocol violations, protocol eligibility issues, accepted medications, and general medical-related study issues

- Review laboratory alerts, and coordinate appropriate follow-up with study site

- Conduct training for the project team concerning the disease, drug, study design and procedures

- Provide consultation to the study team during review of out-of-range laboratory values for clinical and /or protocol significance

- Preview listings of AEs/SAEs, study withdrawal/Discontinuation, lab reports, and subject profiles as defined within the Safety Medical Monitoring Plan

- Participation in DSMB meeting, review and provide the data and inputs for the same

- Ensure all protocol inquires and answers are documented

- Additional tasks may involve attendance and participation at Investigator Meetings, preparation of subject narratives, review of study reports and other documents, preparation and/or review of periodic and interim safety reports

- Conduct a medical review of the Project Plan, Tables and Listings, and the Integrated Clinical Study Reports as appropriate

- Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders

- Liaise effectively and maintain an excellent relationship with the clients and external contacts.

- Trains and mentors new employees (if required)

2. REQUISITE COMPETENCY AND QUALIFICATION

Key Competencies :

- Ability to establish effective working relationships with clients & delivery heads

- Ability to plan & prioritize work effectively

- Ability to effectively work independently, prioritize, multi-task and meet established deadlines

Key Skills :

- Knowledge of global regulatory requirements

- Excellent Team handling and client handling skills

- Good time management skills

- Ability to prioritize and plan projects and work effectively

- Good presentation skills

- Strong interpersonal & communication skills

- Knowledge of Microsoft Office

- Excellent analytics, critical-thinking and problem-solving skills

Qualification: A graduate degree/post-graduate degree in Pharmaceutical Sciences/Life Sciences/Medical Science preferably MBBS/MD.

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