Senior Pharmacovigilance Manager

4 days ago

Gurgaon Gurugram Hyderabad Secunderabad Telangana, India beBeePharmacovigilance Full time US$ 90,000 - US$ 1,20,000
About the Role

We are seeking a skilled professional to lead and oversee our pharmacovigilance team. This role is responsible for ensuring timely and accurate submission of reports related to individual case safety reports (ICSRs) and other safety reporting documents.

This position requires strong leadership, project management skills, and a deep understanding of global drug regulations and safety databases.

Key Responsibilities
  • Leadership and Team Management:
    • Lead the pharmacovigilance team, overseeing tasks such as hiring, training, performance appraisals, and employee counseling.
    • Advise staff on administrative policies, technical issues, and task prioritization.
    • Assign and review project workloads for direct reports.
    • Mentor team members and manage resource needs and issues.
  • Project and Financial Management:
    • Manage projects where Safety and Pharmacovigilance are the primary services.
    • Review study budgets and expenses to ensure all contractual and budgeting issues are upheld.
    • Approve project time cards and invoicing, working with the Finance department to ensure appropriate client invoicing.
  • Compliance and Quality Assurance:
    • Monitor the quality and efficiency of the team's work, ensuring compliance with the scope of work and Safety Management Plan.
    • Assist in developing, reviewing, and approving departmental Standard Operating Procedures (SOPs).
    • Maintain and ensure compliance with SOPs, Work Instructions (WIs), global drug regulations, GCPs, ICH guidelines, and GVP modules.
  • Interdepartmental Collaboration and Business Development:
    • Coordinate with other internal departments to ensure timely review and submission of safety reports.
    • Represent the team at project team meetings and client meetings.
    Requirements
    • A bachelor's degree in a biological science or a related field, or an equivalent combination of education and experience.
    • Professional experience in pharmacovigilance with a background in people management.
    • Excellent MS Excel skills.
    • Experience with ARGUS / ARISg Safety Databases is preferred.
    • Knowledge of SQL / Power BI is a plus.
    • Proven experience with progressive responsibility, demonstrated leadership, and project management skills.
    • Clinical Research Organization (CRO) experience with therapeutic specialties is preferred.
    Benefits
    • Excellent oral, written, and interpersonal communication skills.
    • The ability to be flexible, adapt to change, and manage multiple priorities while delivering high-quality work.

  • Senior Pharmacovigilance Manager

    5 days ago

    Hyderabad / Secunderabad, Telangana, Gurgaon / Gurugram, India beBeePharmacovigilance Full time ₹ 1,04,000 - ₹ 1,30,878

    Job OverviewWe are seeking an experienced professional to lead and oversee our pharmacovigilance team. This role is responsible for ensuring the timely and accurate submission of reports related to individual case safety reports (ICSRs) and other safety reporting documents.The ideal candidate will have a strong background in pharmacovigilance, proven people...

  • Senior Pharmacovigilance Director

    3 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878

    Pharmacovigilance Leadership RoleWe are seeking a seasoned Pharmacovigilance professional to lead our team and drive compliance, regulatory submissions, and pharmacovigilance SOPs.Job Summary:This role involves handling end-to-end Case management activities, ensuring compliance with regulations, and guiding the pharmacovigilance team on aggregate reports and...

  • Senior Pharmacovigilance Leader

    3 days ago

    Hyderabad / Secunderabad, Telangana, India beBeePharmacovigilance Full time ₹ 1,04,000 - ₹ 1,30,878

    We are seeking a Senior Pharmacovigilance Leader to provide strategic direction and leadership for signal detection and management activities in India. This role requires an experienced medical professional with extensive knowledge in global safety practices.Roles & ResponsibilitiesStrategic Leadership: Provide vision and guidance for all signal detection...

  • ROW Market Pharmacovigilance Specialist

    4 days ago

    Hyderabad / Secunderabad, Telangana, India beBeePharmacovigilance Full time US$ 90,000 - US$ 1,20,000

    Job SummaryWe are seeking a highly skilled and detail-oriented Pharmacovigilance Specialist to join our organization. The ideal candidate will have excellent communication and organizational skills, as well as a strong understanding of regulatory requirements in ROW countries.Key Responsibilities:Manage pharmacovigilance tasks, including updating PSMFs,...

  • Pharmacovigilance Associate

    22 hours ago

    Ameerpet, Hyderabad, Telangana, India FORWARD LIFE PVT Full time ₹ 1,70,000 - ₹ 2,20,000 per year

    Job Title: Pharmacovigilance Associate / Drug Safety AssociateLocation: AmeerpetDepartment: Pharmacovigilance / Drug SafetyReports To: PV Manager / Head of PharmacovigilanceJob Purpose:To ensure patient safety by monitoring, collecting, assessing, and reporting adverse drug reactions (ADRs) and other safety information in compliance with global...

  • Associate, Pharmacovigilance

    1 week ago

    Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Data Entry Specialist: Pharmacovigilance

    7 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeTriage Full time

    **Job Description**Within a quality management framework, we are seeking a professional to perform the initial book-in of new cases and ensure compliance with global procedural documents.**Key Responsibilities**Work within a framework that includes all applicable training and controlled documentation governing pharmacovigilance processes.Triage initial data...

  • Associate, Pharmacovigilance

    4 days ago

    Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Pharmacovigilance Associate

    7 days ago

    Ameerpet, Hyderabad, Telangana, India FORWARD LIFE PVT.LTD Full time

    **Job Title: Pharmacovigilance Associate / Drug Safety Associate** **Location**:Ameerpet **Department**:Pharmacovigilance / Drug Safety **Reports To**:PV Manager / Head of Pharmacovigilance **Job Purpose**: To ensure patient safety by monitoring, collecting, assessing, and reporting adverse drug reactions (ADRs) and other safety information in compliance...

  • Research Associate

    4 days ago

    Gurgaon, Haryana, India beBeePharmacovigilance Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Title:Research Associate - Pharmacovigilance SpecialistJob Summary:Assist in the identification and management of adverse drug reactions, conducting systematic literature searches and ensuring compliance with regulatory requirements.Responsibilities:- Conduct comprehensive literature searches to identify safety-relevant information across multiple...