Serm Assoc Medical Director

10-15 years

preferred by company

Bengaluru

10 Nov. 22, 2024

Job Description

Job Type: Full Time Remote Education: MBBS (Bachelor of Medicine, Bachelor of Surgery), MD (Doctor of Medicine), DNB (Diplomate of National Board), BDS (Bachelor of Dental Surgery), MDS (Master of Dental Surgery), BVSc (Bachelor of Veteri Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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: SERM Associate Medical Director
Years of Experience: 10-15 years
Work Mode: Hybrid (3 days in-office)

Job Purpose:

The SERM Associate Medical Director provides medical and scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or post-marketing settings. The role ensures scientifically sound review and interpretation of data, managing safety issues, and escalating them to senior management and safety governance as necessary. The position also focuses on improving the efficiency and effectiveness of pharmacovigilance processes to ensure patient safety globally.

Key Responsibilities:

Scientific/Medical Knowledge & PV Expertise:

Signal Detection & Evaluation: Responsible for signal detection and evaluation activities for assigned products.
Regulatory Reports & RMPs: Drives the production of regulatory periodic reports and associated documentation and Risk Management Plans (RMPs) globally, adhering to agreed processes and timelines. Advises on the content of regulatory reports in collaboration with the product physician.
Global Regulatory Submissions: Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician.
Audits & Inspections: Responds to auditors/inspectors’ requests for additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.
Data Evaluation & Interpretation: Utilizes advanced evaluation skills for literature review, data gathering, synthesis, analysis, and interpretation. Makes sound decisions based on broad data sources.

Cross-functional Matrix Team Leadership:

Safety Governance: Supports and facilitates safety governance and Safety Review Teams (SRTs) in clinical development and post-marketing settings, ensuring that risk-reduction strategies are implemented in clinical study protocols and/or product labelling.
Process Improvement: Leads or participates in cross-functional process initiatives and workstreams to enhance adherence to regulations, data standards, quality, and efficiency. May author or participate in the development of SOPs.
Collaboration & Mentorship: Builds strong collaborative relationships and provides input to matrix teams on safety issues and processes. Coaches and mentors team members.

Communication & Influencing:

Senior Communication: Presents complex safety issues to senior management and governance committees.
Proactive Contributions: Actively contributes ideas to improve operational processes and efficiency.
Medical Writing: Prepares detailed evaluations and reports on major GSK products, demonstrating robust medical/scientific writing skills.
Influencing & Negotiation: Effectively influences and persuades others in the matrix team to understand safety perspectives and facilitates the adoption of safety protocols.

Education Requirements:

Required: Medical Doctor (physician) preferred or equivalent (e.g., veterinarian/dentist with appropriate pharmacovigilance experience).
Preferred: Additional relevant medical or scientific post-graduate qualifications.

Job Related Experience Requirements:

Substantial Experience: Extensive experience in pharmacovigilance or drug development, particularly in safety evaluation and risk management in both clinical development and post-marketing activities.
International PV Requirements: Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
Matrix Organization Experience: Proven experience working in large matrix organizations.

Scope of Accountability:

Support the team-level GSK asset benefit-risk profile and management. May chair Safety Review Teams.
Provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or post-marketing settings.

This role demands a strong combination of pharmacovigilance expertise, leadership abilities, and effective communication to ensure the safety of GSK products and manage risk efficiently.

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