SERM Associate Medical Director

GSK
GSK
WarsawPresencialCompetitivoPublicado hace 6 días
🇬🇧Inglés requerido434714
GSK

SERM Associate Medical Director

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The SERM Associate Medical Director provides medical leadership and subject-matter expertise to Safety Evaluation & Risk Management (SERM) activities across assigned clinical programs within oncology. The role integrates clinical/medical insight with safety and risk assessment processes to identify patient- and study-related risks, shape mitigation strategies, and ensure regulatory and ethical compliance.

Key responsibilities

  • Provide medical oversight and clinical input to SERM risk assessments, safety monitoring and mitigations and overall evaluation of benefit / risk.

  • Interpret clinical data and lead assessment of safety signals

  • Collaborate with team members within Safety, Clinical Development, Regulatory Affairs and other functions to develop effective safety strategies and communications.

  • Contribute to design and review of protocols, risk assessment tools, and medical sections of safety risk documentation.

  • Draft, review, and approve medical content for INDSRs, risk registers and regulatory submissions

  • Participate in cross‑functional governance forums and advise senior leadership on medical implications of safety/risk scenarios.

  • Support training and capability building for colleagues on clinical aspects of safety-related risks and mitigations strategies.

  • Maintain awareness of applicable regulations, guidance, and industry best practice

Why you?

Qualifications:

  • Medical Doctor (physician) preferred; equivalent qualifications (e.g., veterinarian/dentist) accepted with relevant pharmacovigilance (PV) experience.

  • Postgraduate qualifications in medical or scientific fields desirable.

  • Substantial expertise in pharmacovigilance or drug development across clinical and post‑marketing settings.

  • Knowledge of international PV requirements (ICH, GVP, CIOMS) and drug approval processes.

  • Experience working in large matrix organizations.

Why GSK?
At GSK we offer a wide range of additional benefits:

  • Career at one of the leading global healthcare companies

  • Hybrid work ( 2 days per week from the office)

  • Contract of employment

  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

  • Life insurance and pension plan

  • Private medical package with additional preventive healthcare services for employees and their eligible counterparts

  • Sports card

  • Possibilities of development within the role and company's structure

  • Personalized learning approach

  • Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)

  • Supportive community and integration events

  • Modern office with creative rooms, fresh fruits every day

#LI-GSK

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The annual base salary in Poland for new hires in this position ranges from PLN 318,000 to PLN 530,000 gross, taking into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer's discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Candidatura gestionada por GSK