Chemistree Solutions

Pharmacovigilance Director

Location
Cambridge UK / Gothenburg Sweden / Gaithersburg USA / Wilmington, US
Salary
Competitive Salary & Excellent Benefits Package
Posted
25 Jun 2021
Closes
25 Jul 2021
Ref
4584
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Role: Group Director, Pharmacovigilance Epidemiology

Location: Cambridge UK / Gothenburg Sweden / Gaithersburg USA / Wilmington, US 

Salary: Competitive Salary & Excellent Benefits Package

This is a great opportunity to join a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. Turning ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

The Group Director, Safety Epidemiology is a newly created role is a scientifically driven vital position within the Global Medical Evidence Generation team, accountable for driving scientific and operational aspects of Global Pharmacovigilance studies for the company products across specified therapeutic areas. These studies include Post Authorisation Patient Safety Studies (PASS) and Post Marketing Surveillance (PMS) Commitments utilising real work evidence (RWE) across different therapeutic areas. Other responsibilities include vendor management, broad oversight of requests for epidemiological evidence to support epidemiological input into Risk Management Plans (RMPs) and requests for epidemiological evidence in collaboration with Patient Safety Strategy and Management Teams SSAMT).

The Group Director, Safety Epidemiology is accountable for the leadership and management of a team of between 5 - 10 Epidemiologists as well as contracted resources as needed as well as work on individual studies.

This position will be aligned to one or more therapy areas or disease areas to serve as the key Epidemiology Pharmacovigilance contact and strategic partner. The incumbent will lead and develop a group of Epidemiologists within the designated therapy/disease area(s), optimizing individual and team performance, ensuring appropriate deployment to drug projects and other functional activities to build and maintain excellence in pharmacovigilance and epidemiology capabilities. 

This position has management responsibilities for a wide range of activities, including competence development, training, optimal use of resource and skill, and internal company awareness of epidemiology, pharmacovigilance and medical evidence. You will drive recruitment, retention, resource planning, development, and people management of Epidemiologists to deliver the agreed project objectives.

This position will be responsible for developing and leading global epidemiological pharmacovigilance strategy and deliverables, working with Patient Safety and Regulatory leads internally and providing scientific guidance as required. You will also work and coordinate with local markets on mandated post authorisation Patient Safety studies (PASS) requiring local RWE data. In this role, you will work closely with cross-functional internal partners across Global Patient Safety, Global Regulatory, Global/Local Medical, and R&D to develop strategic plans for epidemiology and global pharmacovigilance studies, then ensure studies are designed and implemented in accordance with the regulatory requirements to meet the needs of Patient Safety teams in the company and in anticipation of requests from EMA, FDA and other regulatory agencies.

Typical Accountabilities

Through leadership of the Safety Epidemiology team as well as individual contribution:

Ensure the development and delivery of high quality, scientifically robust evidence on time and on budget.

Ensures effective resourcing of projects.

Lead the recruitment and allocation of appropriately skilled Epidemiologists to projects to ensure delivery of Post Authorisation Patient Safety Studies (PASS) and Post Marketing Surveillance (PMS) Commitments to clinical programs to time, budget and quality in accordance with performance targets.

Work closely with cross-functional teams in considering project resourcing.

Develop and maintain a Safety Epidemiology skills development strategy, proactively identifying and delivering against gaps (e.g., define training needs and capabilities improvement/maintenance activities, partnerships)

Work with Capacity Management to achieve accurate resource forecasting, analysis and solution building to resource projects efficiently and flexibly, considering people development and succession planning.

Ensure individuals are motivated, skilled and developed, providing expertise and mentorship to support creation and implementation of relevant Individual Development Plans.

Act as an ambassador for BPM, providing visibility on the roles and delivering appropriate advocacy whenever possible to ensure company-wide understanding and best usage of the function.

Ensure compliance with policy and SOPs.

Provide technical and strategic input to projects via coaching of direct reports and through leadership review of deliverables (e.g., MARC)

Provides strategic input to the vision and development of a world class Medical Evidence and RWE capability.

Supports the TA Evidence Heads in establishing a close collaboration and interaction with relevant functions in TA (Evidence Leads), BPM, BBU, R&D, and MCs to develop the company’s approach to plan for and meet the needs of regulators, physicians and patients.

May identify and manage master service agreements for external providers.

Advances the company’s reputation and expertise in Epidemiology policy, planning and evidence generation by participating in appropriate external forums e.g., special interest groups of relevant organisations.

Line management of members of the Safety Epidemiology team.

Promote and encourage communication within and across departments.

Recruit, retain and develop personnel through skills development and creation of opportunities for related staff.

Provide performance management, performance assessment and reward proposals for your team.

Ensure policy administration and implementation within the organisation.

Maintain an environment that attracts, develops and retains highly qualified employees.

Ensure that SHE standards are adhered to for direct reports including appropriate work-life balance.

Carry out effective succession planning.

Qualifications:

Ph.D. or equivalent in epidemiology or related health science field and substantial experience in the health care environment. Alternatively, an MSc or MPH with consolidated experience in the health care environment.

The Person/Experience:

Extensive experience in the pharmaceutical industry with broad and deep knowledge of medical evidence generation and safety epidemiology activities and how they relate to product development and commercialization processes at all life-cycle stages.

You will be able to demonstrate strong leadership capabilities.

The ability to influence internal partners and external stakeholders. 

To Apply
If you are suitable for this position please send a copy of your CV. Alternatively call the recruitment team at Chemistree Solutions Ltd. Chemistree is a pharmaceutical and healthcare recruitment specialist.