Manager, Pharmacovigilance

10+ years

Not Disclosed

Bangalore

10 July 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Manager of Pharmacovigilance Content

Location: Bangalore, India
Hours: Monday to Friday, Hybrid Work Mode

Overview:

The Manager of Pharmacovigilance Content is a key role within the Pharmacovigilance department, focusing on overseeing literature screening activities. This position demands advanced expertise in pharmacovigilance, including literature screening methodologies, signal detection, risk assessment, and team management. The Manager will develop and implement strategies to efficiently and effectively extract safety information from scientific literature.

Key Responsibilities:

Literature Screening Management: Oversee and coordinate literature screening activities, including search strategy development, process management, and data extraction. Ensure accuracy, completeness, and consistency in data extraction and documentation.
Team Leadership and Training: Support senior management in recruiting new team members and managing the training and development of the literature review team. Conduct regular refresher training sessions and maintain training records for audit readiness.
Performance Assessment: Evaluate the performance of team members and provide feedback. Ensure compliance with regulatory requirements and internal SOPs in all literature screening activities.
Signal Detection and Risk Assessment: Lead the analysis of literature data to identify potential safety signals and emerging risks. Prioritize signals based on clinical relevance and potential impact on product safety. Conduct comprehensive risk assessments and contribute to risk management strategies.
Strategy Development: Develop and implement strategies for systematic literature screening to identify safety information relevant to pharmaceutical products. Establish best practices and SOPs for literature screening activities.
Cross-Functional Collaboration: Collaborate with cross-functional teams to develop and implement risk mitigation measures. Communicate findings to stakeholders and support safety updates and risk management.
Operational Excellence: Support operational excellence activities, including performance metrics, CAPA monitoring, and acting as a backup for the Senior Manager of Pharmacovigilance when needed.

What You Will Need:

Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or a related field. Advanced degrees (e.g., PharmD, MD, PhD) are preferred.
Experience: At least 10 years of experience in pharmacovigilance or related fields within the pharmaceutical industry, with extensive experience in literature screening.
Expertise: In-depth knowledge of pharmacovigilance principles, adverse event reporting requirements, signal detection methodologies, and risk assessment principles. Strong understanding of pharmacovigilance regulations and guidelines (e.g., ICH, GVP) and experience with regulatory submissions.
Skills: Advanced analytical skills, strong organizational and project management skills, and the ability to lead and mentor a team effectively.

About the Team:

The Pharmacovigilance team at Clarivate provides services to global customers across all therapeutic areas. We offer a supportive work environment with personalized training and opportunities to engage in various aspects of pharmacovigilance and customer engagement.

Equal Opportunity Statement:

Clarivate is committed to equal employment opportunities for all individuals. We comply with all applicable laws and regulations governing non-discrimination in employment.

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Manager, Pharmacovigilance

Job Description

Position: Manager of Pharmacovigilance Content

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