Pharmacovigilance Services Specialist

Skill required: Pharmacovigilance Operations - Safety Writing
Designation: Pharmacovigilance Services Specialist
Qualifications:Bachelor of Aryurvedic Medicine And Surgery/Bachelor Degree in Life Sciences/Master Degree in Life Sciences
Years of Experience:7 to 11 years
What would you do
Oversee responsibilities in delivering service to the client including mobilization of resources required in delivering the service and managing their performance. Work closely with the client project lead and service delivery lead to manage risks, issues, and escalations and drive successful project completion with high qualityResponsible for leading the Signal Management activities including weekly literature review, authoring of signal reports (Signal Management aid Review Team [SMART] reports) and project management of Safety Surveillance team (SST) meeting within the, agreed timeframes and accuracy, in compliance with business miles, standard operating procedures (SOP) and global regulatory requirements, all as documented ilil Quality documents as applicable.
What are we looking for
Educational and Experience RequirementsoMinimum Education requirement:Degree in Life Sciences or Healthcare degreeoWork experience requirements:Minimum of 3 years of Aggregate report experience with 3 years of signal management process experienceoWorking knowledge of Good Clinical Data Management Practices, GVP (Good Pharmacovigilance Practices), ICH Good Clinical PracticesoExperience with MS Office productsoAbility to work independently under tight time constraintsoGood interpersonal skills and the ability to, operate effectively in an international environment

Good understanding of Patient/Drug safety, Individual Case Safety Reports and Global Regulatory requirements.

Creative approach to problem solving and good lateral thinking skills.

High energy and drive to lead large teams.

Comfortable working in a dynamic business environment

Sound Communication Skills and Analytical Ability.

Strong interpersonal and leadership skills.

Ability to work independently under tight time constraints.
Roles and Responsibilities: Resource management

Coordination and Supervision - Coordinate, manage and monitor workings of various processes in the organization, including but not limited to translations, tool/system access requests, Product/Study configurations, Literature Full text approvals, Query management, case deletion approvals.Staff Management Development

Recruit, hire and reward high performing individuals to meet goals. Facilitate resource evaluation needs across sites. Process Technology

Understand and work to the current divisional/departmental SOPs, ensuring deviations are documented appropriately. Propose new and revise current procedures as appropriate. Client Management

Ensure adherence to clients policies and procedures.

Maintain procedures in adherence to the clients policies.

Ensure all the client SLAs and KPIs are met.

Assist in audit and inspections.

Ensure all relevant governance documents (slides and minutes) are archived in the respective folders

Other essential duties include drafting pharmacovigilance agendas and meeting minutes; accurately archiving pharmacovigilance documents; reviewing safety case data and other pharmacovigilance documents for completeness and accuracy.

Tracking, submitting and distributing of reports; trouble shoot issues if any; assisting liaisons with the partners and cross-functional team members to ensure compliance; supporting various ad-hoc deliverables or pharmacovigilance projects; and participating in audits and inspections.

To perform assist and contribute to transition related activities as per the client requirement.

To perform TMF review and update.

To provide relevant approval as per SOP/SWI

To perform compliance related quality check, monthly review of Literature articles as per the guidance documentLiterature review:On a weekly basis, review abstracts and articles for safety signals and/or for possible inclusion in the aggregate reports and record assessments in appropriate trackers. o Liaise with Global Safety Officer (GSO") Pharmacovigilance (PV) Scientist if a potential safety signal is identified upon review of the weekly alerts or in case of doubt. summary of articles of interest for GSO review with PV Scientist in copy in advance of the SMART meetings. o Complete the Literature Search Alert Tracker once GSO response received

SMART Meeting

SST Meetings

Perform the Signal management activities as per SOPs, Job Aids and guidelines as agreed during the SMART meetings and/or weekly team meeting
Qualification Bachelor of Aryurvedic Medicine And Surgery,Bachelor Degree in Life Sciences,Master Degree in Life Sciences