Medical Director, Global Drug Safety Product Leader
Merck - Billerica, MA

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KEY ACCOUNTABILITIES

The role of the
Global Drug Safety 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
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;

  • Ensure
appropriate oversight of the emerging safety profile of the
product, 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;

  • 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
Product Team; chair the SRT and IRMA 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, collaboration with colleagues from partnership
companies for co-development or co-marketing etc;

  • Provide
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.

STRATEGIC IMPACT

  • Provide
strategic safety leadership for product or group of 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 Safety Signal Committee
for product specific topics

SCOPE OF PEOPLE RESPONSIBILITY

Lead a team of
Global Drug Safety Advisors working on the product

Interfaces with other Departments/Functions:
  • Internal
GDSM groups and GDS groups (Global Drug Safety Operations, Global
Drug Safety Science, Global Drug Safety Compliance &
Standards ,Global Drug Safety Regions, EU QPPV)

  • GCDUs,
GRA, GCO, Medical Information and Communication, MASC, Corporate
Communication, GPU, Business Units.

  • Global
Product Teams, Clinical Development Teams, Submission Teams

External Interfaces:
  • Regulatory
Agencies, Consulting experts, members of IDMCs/DSMBs and
co-development partners as appropriate

  • Must be
prepared to describe and demonstrate these job attributes to
regulatory authority inspectors during pharmacovigilance or other
regulatory authority inspections

Qualifications

EDUCATION

MD with broad clinical experience or Master of Science/Ph D
with profound work experience in pharmacovigilance area

Fluent in written and spoken English

WORK EXPERIENCE

  • Industry
experience, preferably including both clinical development and
pharmacovigilance experience (including medical safety evaluation
and safety based decision making)

  • 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)

  • Specifies
personal skills and competencies required

  • 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)

Merck - 22 months ago - save job
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Merck makes medicines for a number of maladies, from stuffy noses and asthma to hypertension and arthritis. The pharmaceutical giant's...