Pharmacovigilance Safety Physician

Are you a physician with several years of broad pharmacovigilance experience? Do you want to join one of the fastest-growing generics and biosimilar pharmaceutical companies in the world? 

Invenia Group is partnered with a leading international pharmaceutical company that is currently seeking an expert in Signal Management to take on the role of Pharmacovigilance Safety Physician, EMENA. This is a fantastic opportunity to join a team of bright technical minds and forward-thinking business professionals. This position is remote within Europe so we are actively hiring candidates based anywhere within Europe.

Role responsibilities: 

The Safety Physician will provide medical expertise regarding the safety and risk assessment of products at all stages of the product lifecycle as well as be the lead for signal management within the safety and risk management pharmacovigilance team.

Responsibilities will also include the development and implementation of policies and procedures (aligning with requirements of regulatory authorities, global policies, and best practices) relating to signal management as well as medical support within the EMENA pharmacovigilance and medical information department at the company. You will also be responsible for the following:

• Demonstrate strong medical knowledge and analysis for PV-specific documents when needed
• Lead, oversee and provide guidance on the signal management process
• Ensure proper MAH medical review of signal detection reports delivered by the service provider
• Oversee the outcomes from signal detection activity
• Participate in the maintenance of the safety profile of the company’s medicinal products
• Participate in safety-related review committees and relevant meetings
• Support the scientific affairs leadership team in both regulatory and medical affairs with advice and input
• Assist in the medical assessment of clinical safety requirements in protocols, safety management plans, or contracts
• Actively participate in regulatory authority pharmacovigilance inspections
• Provide backup to the safety & risk management team members
• Help in building and maintaining a visible role of pharmacovigilance within the organisation

What we are looking for: 

We are looking for a physician with several years of broad pharmacovigilance experience who must reside and operate within the EU or UK. You must have experience in global pharmacovigilance setups, with special reference to signal management, and experience in continuous communication with CROs or vendors, as well as the following:

• Thorough understanding of the cross-functional drug cycle processes and context applicable to safety surveillance activities
• Must have proven decision making and problem-solving skills
• Must have excellent communication and interpersonal skills
• Strong attention to detail and persistence in following tasks through to completion
• Good organisational and prioritisation skills

If you are interested in proceeding with this opportunity, please apply so we can arrange a confidential discussion to discuss the position in more detail.