General Manager/Assistant Vice President/Vice President - Pharmacovigilance - MBBS

Organization: Pharmacovigilance / Clinical research organization

Position : GM/ AVP/ VP Pharmacovigilance

Location: Ahmedabad

Experience: 13 - 20 yrs

CTC: 40 - 60 LPA ( Depending on current CTC and overall experience )

Qualification: MBBS (From India only)

Roles & Responsibilities :

- Managing the client deliverables for clients and responsible for project management at the operational level including executing, controlling and monitoring ongoing projects.

- Responsible for liaising with the clients.

- Responsible for having an overview of the complete safety profile of the client's products

- Responsible for the Budgeting activities for projects

- To Oversee the day-to-day operations of the Clinical, Medical Affairs & Pharmacovigilance department

- Developing and overseeing the long term business strategies of the department and keep management fully informed timely the conduct of the day-today operations.

- Development of strategy and procedures for integrating cross functional team members -

- Selection and recruitment of staff. Staff appraisals and performance management.

- To guide and train employees to use more effective methodologies and improve efficiency.

- To Oversee Clinical trial Management to ensure assigned projects run within budget and that deliverables are met as per contract.

- To review compliance (quality, procedures, regulations, timeliness, consistency) of all ICSR and Aggregate reports in accordance to applicable regulatory and client requirements.

- Reviewing and authorizing the on-going enhancement of processes and Standard Operating Procedures.

- Ensuring compliance with local regulations and Company global Requirements.

- Reviewing inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues.

- Marketing and business development of services and generation of new business leads.

- Input into bids, proposals and contracts. Ensures that the Company remains compliant with reporting both expedited and periodic reports to the relevant regulatory authorities by means of compliance monitoring.

- Oversees and authorize the development for validation, operation and change management of the safety database and maintains oversight of the related processes and procedures to ensure that all adverse events reported and are recorded.

- Ensuring that all processes conducted throughout by appropriate SOPs and Instructions that explain such processes and are in accordance with pertinent regulations.

- Ensures that all SOPs are reviewed and authorized periodically and amended in the light of changes to relevant guidelines and other legislation pertinent to Clinical Trials & Pharmacovigilance.

- Ensures that all relevant personnel involved are appropriately trained on processes based on their job delegation and also on the use of applicable SOPs and that records of training are maintained.

- Foster a corporate culture that promotes ethical practices, customer focus and service and encourages individual integrity.

- Maintain a positive and ethical work climate that is conducive to attracting, retaining and motivating employees at all levels.

- Oversees and authorize the design and implementation of training programs for the team Strategic insights to in design and conduct of clinical program.Ensuring adequate record management.

- Global Pharmacovigilance, Coordinating ICSR processing, Medical coding and Medical review,Narrative preparation,Aggregate reports like PSUR; RMP; REMS ; Signal detection and validation,Overall Benefit-risk evaluation of medicinal products, Training of team on various regulatory guideline and regulations,Handling of PV audits,Implementation of a safety system, safety variations and improvement in safety processes.

- Training and mentoring of team members depending upon the project requirement. Management of Compliance with the Company Standard Operating Procedures and with regulatory requirements.

- Generation and execution of Standard Operating Procedures.Maintain awareness of changes to/new regulations affecting Pharmacovigilance Activities.

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