Years of Experience: 10-15 years
Skill Set / Exposure: PV, Aggregate Reporting, Signal Detection, Risk Management Plans.
Work Location: Bengaluru [Hybrid Mode (3 days office)]
Job Purpose:
- Provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
- Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate.
- Makes recommendations for the further characterization, management, and communication of safety risks.
- Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs.
- Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
- If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors.
- Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.
Key Responsibilities:
Scientific/Medical Knowledge PV Expertise:
- Responsible for signal detection and evaluation activities for assigned products.
- Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).
- Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician.
- May respond to auditors/inspectors’ requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.
- Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.
- Makes sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identifies, evaluates, and recommends solutions to problems.
- Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.
Cross-functional Matrix team leadership:
- Supports and Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
- Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.
- May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
- Builds strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others.
Communications (verbal, written) and Influencing (internal PV Governance and External LTs):
- Presents complex issues to senior staff members at the GSK Senior Governance Committees.
- Demonstrates initiative and creativity in performing tasks and responsibilities. Proactively contributes ideas to improve existing operations.
- Proactively contributes ideas to improve existing operations.
- Participates in process improvement initiatives within GCSP and contributes to advancement of methodology and process by generating new ideas and proposals for implementation.
- Possesses effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listens and responds appropriately to the views and feedback of others.
- Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role.
- Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective.
Education Requirements:
SERM Assoc Medical Director
- Medical Doctor (physician) preferred, (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.
- Job Related Experience Requirements
- Substantial experience in pharmacovigilance or drug development.
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
- Experience working in large matrix organizations.
Scope of Accountability:
- Support Team Level GSK asset benefit risk profile and benefit risk management. May chair Safety Review Team.
- Provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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