EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.
The role of the Global Drug Safety Fertility Product Leader is to ensure effective proactive safety strategies for the assigned product(s) be it a development compound or a marketed product; delivery of safety aspects input to clinical development; and risk management and benefit-risk evaluation for the product. This includes delivery of the medical evaluation of single cases; signal detection and evaluation activities; all periodic safety reports, risk management plans and regulatory documents; ensuring definition, implementation and evaluation of risk mitigation actions, and safety input to clinical trial activities as appropriate.
For the assigned Fertility product or products, either directly or through effective delegation to other members of the GDS Product Team:
- Ensure provision of a clearly defined safety strategy, in the context of delivering the benefit-risk profile, and ensure that plans in place are consistent with delivering this strategy; perform any activities requested by TA head to accomplish this goal;
- Ensure appropriate oversight of the emerging safety profile of the product (s), including review of individual safety cases, signal detection and evaluation, periodic reporting, risk-benefit evaluation and risk management, and that any significant signals or safety issues are escalated appropriately within the company; maintaining current and accurate records of signal detection activities, including weekly signal detection review meetings and monthly meetings with TA head;
- Ensure delivery of safety aspects to clinical trial activities as appropriate;
- Maintain an appropriate level of knowledge about the product and the therapeutic area;
- Coach, support and help develop the other GDS staff in the relevant GDS Fertility Product Team; chair BRAT teams, and SMCs as required;
- Represent GDS on cross-functional teams for the product, including eg the GPT, CPT, Submission Team, and any Alert Action Teams, ensuring that all negotiated and agreed deliverables and deadlines for these teams are met (may be delegated as appropriate);
- Represent GDS on safety aspects for the product externally, eg engagement with DSMBs/IDMCs, preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders, due diligence activities, collaboration with colleagues from partnership companies for co-development or co-marketing etc;
- Provide Fertility product or TA-specific training to GDS colleagues, and safety training to non-safety colleagues, as required
- Ensure effective communication of product-related aspects in regulatory authority inspections
- Major financial impact: Lack of appropriate safety strategy for product and potential non conformity to regulatory authority obligations may have significant negative implications on drug development programs and/or marketing authorizations
- Provide strategic safety leadership for a specific Fertility product or the group of Fertility products
- Act as a member of a GPT or Life cycle management team as appropriate
- Provide a single initial point of contact within GDS for all aspects relating to the safety of the product
- Present to Medical Safety and Ethics Board and GDS SMB for product specific topics
SCOPE OF PEOPLE RESPONSIBILITY
- Management of people
- Lead a team of Global Drug Safety Advisors working on the product if appropriate
- MD (University degree) with broad clinical experience with profound (at least 7 years) work experience in pharmacovigilance area
- Formal coursework in epidemiology, biostatistics or equivalent analytic training preferred but not required
- 10 years of industry experience, preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety based decision making) preferred
- Excellent knowledge of product development process and experience of cross-functional team work.
- Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
- First hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good understanding of the therapeutic area
- Professional experience in an international environment
- Several years of industry experience (minimum 5 years)
JOB-SPECIFIC COMPETENCIES & SKILLS
- Strong, mature project leadership and influencing skills
- Entrepreneurial thinking and striving to move project forward, within budget and timelines
- Strong team player and excellent networking skills
- Proven ability to chair meetings effectively
- Solution and results orientated
- Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets
- Excellent verbal and written communication skills (in English language)
- Data analytic skills (eg construction and interpretation of pivot tables in Microsoft Excel, prior experience with data analysis programs preferred)
- Normal and routine office duties
- Position requires both domestic and international travel up to 15% of time
- Fluent in written and spoken English
Equal Employment Opportunity
The Company is an Equal Employment Opportunity employer.
No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.
This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.