Manager, Pharmacovigilance

10+ years

Not Disclosed

Bangalore

10 July 26, 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

Job Title: Manager of Pharmacovigilance Content

Company: Clarivate

Location: Bangalore, India (Hybrid Work Mode, Monday-Friday)

About the Role:

As the Manager of Pharmacovigilance Content, you will oversee all literature screening activities within the Pharmacovigilance department. This position requires advanced expertise in pharmacovigilance, including literature screening methodologies, signal detection, risk assessment, and team management. You will be responsible for developing and implementing strategies to ensure efficient and effective identification of safety information from scientific literature.

Key Responsibilities:

Literature Screening Management: Oversee and coordinate literature screening activities, including developing search strategies, managing the screening process, and extracting data.
Training and Development: Assist in recruiting new team members, provide in-house training for new recruits, and organize regular refresher training sessions. Assess trainee performance and maintain training records ready for audit.
Team and Customer Management: Manage communication and negotiation with customers regarding business operations. Ensure accurate, complete, and consistent data extraction and documentation, providing guidance and support to the team.
Signal Detection and Risk Assessment: Lead the analysis of literature data to identify potential safety signals and emerging risks. Prioritize signals for further evaluation based on clinical relevance and impact on product safety profiles. Conduct comprehensive risk assessments and contribute to risk management strategies.
Strategy Development: Develop and implement strategies for systematic literature screening to identify relevant safety information. Establish best practices and standard operating procedures (SOPs) for literature screening activities, ensuring regulatory and industry compliance.
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.
Quality and Performance Management: Oversee the Literature Screening team with a focus on quality and accuracy. Provide mentorship, conduct performance reviews, and create flexible training programs. Monitor team metrics and CAPA activities.
Backup Support: Act as a backup for the Senior Manager of Pharmacovigilance as needed.

Qualifications:

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or a related field. Advanced degree (e.g., PharmD, MD, PhD) preferred.
At least 10 years of experience in pharmacovigilance or related fields within the pharmaceutical industry, with extensive experience in literature screening.
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.

About the Team:

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

Equal Employment Opportunity:

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

Apply Now: If you have the expertise and experience for this role, we encourage you to apply and join our team in delivering critical safety information and contributing to the advancement of pharmacovigilance.

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Manager, Pharmacovigilance

Job Description

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