SERM Director or SERM Associate Director

Job description

Nombre del sítio: USA - Pennsylvania - Upper Providence
Fecha de publicación: Feb 20 2024

This position will consider candidates at an Associate Director or Director level dependent on individual qualifications.

As a SERM Director or SERM Associate Director you will be responsible to provide in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets, or in clinical development and/or the post-marketing setting. 

This role 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.

Key Responsibilities :

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

1.         Scientific/Medical Knowledge PV Expertise

•             Leads Pharmacovigilance and Risk Management Planning and implementation and develops strategy for approach to evaluation of issues in the clinical matrix.

•             Leads the safety component of global regulatory submissions, including aggregated safety reports and labelling activities.

•             Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation and support to clinical study teams.

•             Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.

•             Demonstrates highly developed multi-tasking skills, ability to prioritize tasks and consistently delivers on deadlines, with high performance standards for quality.

•             Explores positions and alternatives to reach mutually beneficial agreements and solutions.

2.         Cross-functional Matrix team leadership

•             Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.

•             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.

•             Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.

•             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.

•             Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.

•             Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).

•             Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others.

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

· 
Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organization. In addition, is expected to represent GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.

· 
Leads cross-functional process improvement team within GSK.

· 
Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. Contributes to development of long-term strategy for clinical programs.

· 
Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.

· 
Leads inspection readiness and prepared as needed to support audits/inspections.

· 
Excellent communication (verbal, written) and influencing (internally and externally) skills.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Director level role:

· 
Degree in Health Sciences/Health Care Professional required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D)

· 
7 or more years of experience in the Pharmaceutical or Biotech industry working in Medical Affairs, Pharmacovigilance, Drug Safety or a related field

· 
5 or more years of Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities

· 
Experience with international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes

· 
Experience working in large matrix organizations

Associate Director level:

· 
Degree in Health Sciences/Health Care Professional required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D)

· 
5 or more years of experience in the Pharmaceutical or Biotech industry working in Medical Affairs, Pharmacovigilance, Drug Safety or a related field

· 
3 or more years of Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities

· 
Experience with international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

· 
Advanced degree preferred

· 
Accountable for product team level GSK asset Benefit Risk profile and Benefit Risk management

· 
Experience providing medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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