Serm Principal Physician

**Site Name**: Bengaluru Luxor North Tower

**Posted Date**: Jun 28 2023

**1.Scientific/Medical Knowledge PV Expertise**:

- Responsible for signal detection and evaluation activities for assigned products.
- Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
- Assists in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
- Authors regulatory periodic reports and associated documentation globally according to the agreed process and timelines - reviews and contributes to production of program documents such as protocols and aggregate safety reports.
- Acts as a member of a process improvement initiative team within GCSP.
- Completes any post audit/inspection activities within the required timeline
- Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/problems, and makes decisions with consultation of SERM physician.
- Shows commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality. Able to prioritise own workload with mínimal guidance.

**2.Cross-functional Matrix team leadership**:

- Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safety issues.
- Supports 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.
- Mentoring of junior SERM colleagues, can contribute to evaluating the activities of junior colleagues. Can explain knowledge and skills, and work in new situations. Early capability for Safety Lead role.

**3.Communications (verbal, written) and Influencing (internal PV Governance and External LTs)**:

- Shares ideas with line manager on ways to improve processes for assigned tasks.
- Ability and willingness to adjust behaviours and priorities based on changing environment.
- Able to deal with ambiguity and resilient, focused, and optimistic under pressure.
- Demonstrated effectiveness in both oral and written communication. Able to effectively express ideas and incorporate feedback into deliverables to create a quality output.
- Thorough medical/scientific writing skills are important, as the preparation of detailed evaluations and reports is a core feature of the role.
- Supports a safety risk positions
- Keeps manager/supervisor informed of progress and activities; escalates issues as appropriate.
- Able to present merits of own point of view.

Education Requirements (minimum expected)

**SERM Principal Physician**
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

Relevant 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

Safety signal detection, assessment, and risk management. May chair Safety Review Team.

Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.

**1.Scientific/Medical Knowledge PV Expertise**:

- Responsible for signal detection and evaluation activities for assigned products.
- Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
- Assists in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
- Authors regulatory periodic reports and associated documentation globally according to the agreed process and timelines - reviews and contributes to production of program documents such as protocols and aggregate safety reports.
- Acts as a member of a process improvement initiative team within GCSP.
- Completes any post audit/inspection activities within the required timeline
- Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/problems, and makes decisions with consultation of SERM physician.
- Shows commitment to the task and effective time management to meet multiple deadlines successfu