- Full Time
- Karnataka ; Noida, Uttar Pradesh, India
Website Clarivate
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ToggleJob Title:
Manager, Pharmacovigilance
About Clarivate
Clarivate is a global leader in providing innovative solutions designed to accelerate the lifecycle of invention. With a bold mission to help customers solve some of the world’s most complex challenges, Clarivate empowers organizations with actionable insights to bring ideas to life-changing innovations faster. Our trusted subscription and technology-based solutions, combined with deep domain expertise in science and intellectual property, help customers discover, protect, and commercialize their inventions.
Position:
Manager, Pharmacovigilance
Job Description
The Manager of Pharmacovigilance Content will lead and oversee all literature screening activities within the Pharmacovigilance department. This position demands a deep understanding of pharmacovigilance, including literature screening techniques, signal detection, risk assessment, and strong team leadership skills. The Manager will be instrumental in developing strategies to ensure the timely and effective identification of safety information from scientific literature.
Key Responsibilities
- Oversee and manage all literature screening processes, including developing search strategies, managing the screening process, and extracting relevant data.
- Support operational excellence initiatives and assist senior management in recruiting and onboarding new team members.
- Provide ongoing training and development for the Literature Screening team, including organizing regular refresher sessions.
- Communicate and negotiate with customers on business operations as necessary.
- Conduct performance assessments for trainees and maintain accurate training documentation for audit readiness.
- Ensure accuracy, completeness, and consistency of data extraction and documentation, providing guidance to the Literature Screening team.
- Lead the analysis of literature data to detect safety signals and emerging risks.
- Conduct risk assessments of identified safety signals and contribute to risk management strategies.
- Develop best practices and standard operating procedures (SOPs) for literature screening, ensuring regulatory compliance.
- Collaborate with cross-functional teams to implement risk mitigation measures.
- Ensure all literature screening activities align with internal SOPs and regulatory requirements.
- Mentor and guide the Literature Screening team, conducting performance reviews and fostering professional growth.
- Act as a backup for the Senior Manager Pharmacovigilance as required.
Candidate Profile
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or a related field. Advanced degree (PharmD, MD, PhD) preferred.
- A minimum of 10 years of experience in pharmacovigilance, particularly in literature screening within the pharmaceutical industry.
- Extensive knowledge of pharmacovigilance regulations, adverse event reporting, signal detection, and risk assessment.
- Familiarity with pharmacovigilance regulations (e.g., ICH, GVP) and experience with regulatory submissions.
Additional Information
- Experience: At least 10 years in pharmacovigilance or related fields.
- Qualification: Bachelor’s or Master’s Degree in Pharmacy or Life Sciences.
- Location: Karnataka; Noida, Uttar Pradesh, India.
- Functional Area: Life Sciences & Healthcare.
- Application Deadline: 30th October 2024.
Join Clarivate and contribute to a team that drives innovative solutions for the pharmaceutical industry. Apply now and help shape the future of life-changing innovations.
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